Drug Registration Manager Stellenangebote

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Stellenangebote Drug Registration Manager Jobs bei StepStone

Job vom 30.10.2024 SCHOTT Pharma AG Co. KGaA

Manager Regulatory Affairs (m/f/d)

• Mainz Beratungs-/ Consultingtätigkeiten Homeoffice möglich

MEHR

SCHOTT Pharma AG Co. KGaA sucht in Mainz eine/n Manager Regulatory Affairs (m/f/d) (ID- Nummer: 11660499) . SCHOTT is a leading international technology group in the areas of specialty glass [...] regulatory issues with agents and consultants Lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business Serve as the go- to advisor and trainer for internal SCHOTT- Pharma- specific regulatory topics, such as National Product Registrations and Drug Master Files (DMFs) Roll out and oversee standards and central specifications for Dossier- structures across global markets for our customers Ensure product- dossier compliance across our various sites for global registration procedures of our customers Prepare response documents for official inquiries and provide statements for product registrations Identify and define regulatory [...]

Stellenangebote Drug Registration Manager Jobs bei Jobleads

Job vor 5 Tagen gefunden Senior Process Manager MSAT • Basel, Basel- Stadt

MEHR

[...] Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra- rare disease patients who are in need of life saving treatments Job Description The right candidate will manage the following tasks: Subject matter expert (SME) for Drug Substance of small molecule, non sterile dosage forms. Process owner of Drug Substance small molecule, non sterile dosage forms validation [...] up, execution and documentation of technical studies, qualifications and validations. Contribute during set up of new analytical specifications and stability programs and review changes thereof. Write and review applicable sections of the APR/ PQR. Write and review applicable sections in registration files, variations and market expansion. Lead and execute MSAT projects such as manufacturing process and cost improvement as part of [...]

Job vor 14 Tagen gefunden

Director CMC (Reporting to Vice President CMC IP)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

[...] chemistry, formulations, our internal team of experts and various CDMOs integrated into the pharmaceutical development of our product candidates from preclinical stage to commercial. Key focus of your work will be the new pharmaceutical product application and preparation of commercial drug supply of our proprietary lead product candidate. Responsibilities: Manage Chemistry, Manufacture and Analytical Control of the entire development products from early phase I up to submission for market authorization. Lead the CMC aspects of product development programs and manage the Pharmaceutical Development group. Provide scientific and technical expertise into selection of new drug candidates and development programs. Validation and registration batch generation for drug substance and drug product Process validation and qualification of analytics for Phase 3 product candidate Setup [...] requirements. Experienced in complex project management, negotiations with external partners and Due Diligence processes Audit experience Capacity of effectively organizing and monitoring projects and plans with attention to detail and deadlines to secure progress and goal achievement Persuasive pro- active manager and trustful, reliable person with entrepreneurial spirit, who generates enthusiasm and positive group dynamics Excellent team- oriented leadership and management [...]
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Job vor 14 Tagen gefunden REGULATORY AFFAIRS PROJECT MANAGER • Basel, Basel- Stadt

MEHR

[...] encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary As Regulatory Affairs Project Manager, you will be responsible for managing various projects for Alira Health clients with the support of Senior regulatory experts and subject matter experts within Alira Health. You will have the opportunity to support clients in a broad range of drug development activities from early to late stage of development, to address client issues and to achieve project objectives. We are [...] or pharmaceutical industry. Job Description ESSENTIAL JOB FUNCTIONS Develop and lead regulatory activities for their own projects with support of Alira Senior Director/ SVP if needed e. g. : Provide regulatory strategy advice for entry to human, clinical development or registration. Prepare Health Authorities interaction in collaboration with other functions. Prepare and submit packages for regulatory agencies e. g. EMA, EU [...]

Job vor 14 Tagen gefunden

Regulatory Affairs Manager

• Martigny, Wallis

MEHR

[...] registered with the main regulatory authorities. The Company is a world leader in polylactic- co- glycolic acid (PLGA) - based injectable, sustained- release technology. For his Regulatory Affairs Department, Debiopharm Research Manufacturing in Martigny is looking for a REGULATORY AFFAIRS MANAGER, 100 Your Mission : Manage all post marketing regulatory activities of chemical pharmaceutical drug products including renewals, CMC variations, update of Labeling, extension of indications. Your Responsibilities : Maintenance of registration files for all post- approval activities. To author, review and lead high quality documents for regulatory submissions. Prepare response to [...]
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Job vom 04.11.2024 Associate Director Analytical Operations/ Head External Analytical Organization (f/m/d) Führungs-/ Leitungspositionen

MEHR

[...] #LI- Hybrid As Associate Director or Head of Analytical Operations you will lead and direct the team managing external partners, global projects, networks, and/ or platforms. Prioritize customer needs and ensure alignment of own and team activities with the overall drug development process. Be directly accountable for maximizing resource utilization within your team or for a specific activity. Lead budget and [...] expertise to ensure compliant and efficient externalization of analytical work packages across biologics (Bx) Analytical Development (Bx AD) . Ensure effective management of all project- related activities with contractors, aligning their timelines with project milestones. Support high quality of international registration documents via close collaboration and alignment with the Analytical Project sub- team. Consistently and actively assess and expand potential externalization [...] REQUIREMENTS: Education and qualification: Minimum: Degree in engineering, management, science or equivalent (MSc. , MBA, Ph. D. or equivalent) with corresponding experience. Languages: Fluent in English (oral and written) . Successfully demonstrated several years of directly related experience as people manager. Proven track record of creativity, problem solving and productivity in projects. Thorough understanding of development processes in TRD. Demonstrated successful [...]

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Stellenangebote Drug Registration Manager Jobs bei Job-Consult

Job vom 16.09.2024 Recruiter Vitaly Pryadka

Pharmacist, France

• Lorraine/ (Frankreich)

MEHR

[...] pryadka lorraine responsabilits for our client a hospital center we are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical parmacy computerization of the drug circuit sterilization quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists rmunration monthly salary between and net month requirements expectations be a national [...]
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Job vom 28.06.2024 PhD- Jobs. NET Pharmacist • France/ (Frankreich)

MEHR

[...] jobs net france for our client a hospital center we are looking for pharmacists the current team is composed of pharmacists the job profiles we are looking for are oriented on the following sectors pharmacotechnics clinical pharmacy computerisation of the drug circuit sterilisation quality assurance manager other requirements pharmacist meeting the requirements of the decree of january concerning the conditions of exercise in pui registration to the list of aptitude of hospital pharmacists remuneration and benefits monthly salary between and net month requirements and expectations [...]

Stellenangebote Drug Registration Manager Jobs bei NewScientist Jobs

Neu Job vor 6 Std. gefunden Devon Partnership NHS Trust

Clinical Practice Lead

• Exeter, United Kingdom, Devon Führungs-/ Leitungspositionen

MEHR

Job summary Weare looking for a Clinical Practice Lead to join Exeter Home Treatment Team providing mental health and treatment and care for those who need it. Thepost- holder for this role will be working closely with our Clinical Team Manager and Senior Nurse Manager across the Exeter Home Treatment Team to develop clinical practice andbolster our leadership team. This role [...] Evidence of working therapeutically with individuals Working with people presenting in mental health crisis Ability to interpret research and apply to practice Knowledge and utilization of counselling skills/ cognitive behavioural skills, psychosocial interventions Experience in the management of clients with drug and alcohol problems/ dual diagnosis Experience of carrying out assessments, identifying the appropriate care pathways and confirming diagnosis Other relevant post registration experience Understanding of research principles Desirable Teaching, training and/ or supervision of clinical staff Clinical leadership Qualifications Essential A professional [...]

Neu Job vor 6 Std. gefunden Ashford St. Peter s Hospitals NHS Foundation Trust Clinical Practice Educator in Maternity • Chertsey, United Kingdom, Surrey

MEHR

[...] their team. You would need to be confident in a teaching environment and have experience in mentoring. This role is predominately supporting shop floor learning on the wards through bedside learning. We want you to support our junior workforce with drug rounds and help them to achieving their competencies in a safe learning environment. We want someone who is nurturing that [...] Provide mentorship, coaching, supervision and shadowing opportunities to each individual to support their professional development. Produce relevant teaching material tailored to meet specific learning requirements. Actively participate in maintaining your own professional development, identifying your own training needs with Line Manager. To facilitate staff in all clinical settings to gain sufficient clinical competence including IV cannulation, episiotomy and perineal suturing. Governance [...] had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. . UK Registration Applicants must have current UK professional registration. For further information please see Additional information Disclosure and Barring Service Check This [...]
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Neu Job vor 6 Std. gefunden Oxford University Hospitals NHS Foundation Trust

Clinical Trials Pharmacy Technician

• Oxford, United Kingdom, Oxfordshire

MEHR

Job summary NHS AfC: Band 4 to 5 progression post : Clinical Trials Pharmacy Technician- Permanent Hello, My name is Lina and I am Clinical Trials Pharmacy Technician Team Manager for the Clinical Trials team in Oxford. I am extremely privileged to manage and support our fantastic technical team of [...] a Clinical Trials Pharmacy Technician in our team, you will have an extremely varied role- you will be involved in maintaining the supply chain of Clinical Trial medications to research nurses who deliver treatment to patients, maintaining financial records, completing drug accountability activities, closing down and archiving of completed studies, as well as facilitating meetings from sponsors. A successful candidate should possess relevant Pharmacy Technician qualification and registration with GPHC. Please make sure that you read the job description and person specification attached below, and that your statement [...]

Job vor 9 Tagen gefunden West Hertfordshire Hospitals NHS Trust Band 8b- Principal Clinical Scientist, Chemical Pathology • Watford, United Kingdom, Hertfordshire

MEHR

[...] Hertfordshire and West Essex Integrated Care Board (ICB) . Health Services Laboratories (HSL) is the newly appointed provider for this forthcoming shared networked pathology service This role requires working closely with Consultants, Team Leaders, Quality Leads, and Chemical Pathology operation manager and Blood Sciences manager. Person specification Education and qualifications Essential criteria First Degree or assessed equivalent of knowledge and expertise. Master s Degree or assessed equivalent level of knowledge and expertise in speciality of Clinical Biochemistry. Fellow of Royal College of Pathologists (FRC Path) as required for Medical Consultant. Demonstration of Continuing Professional Development at agreed level of participation. Registration as a clinical scientist with Health and Care Professions Council (HCPC) . Desirable criteria PhD Knowledge Essential criteria To have a thorough knowledge of human biochemistry and chemistry including metabolic processes, physiology, pharmacology and drug interference. To have a sound basic knowledge in other areas of Pathology. To have an extensive knowledge of routine and [...]

Job vor 11 Tagen gefunden Royal Free London NHS Foundation Trust

Band 8a Clinical Endoscopist

• London, United Kingdom, London (Greater)

MEHR

[...] results and interprets the findings and communicate to GPs, medical consultants, patients and carers. 7. Possess and demonstrate extensive, complex clinical skills and be able to deliver specialised nursing care, e. g. , Physical examination, I. V. cannulation, I. V. drug administration, venepuncture. Non- Medical Prescribing 8. As a registered Nurse Prescriber or Independent Prescriber, the practitioner will undertake prescribing duties [...] 26. Act as a communication channel to all different staff groups, patients and relatives, as well as staff in other disciplines and agencies. 27. Provide professional guidance and advice whilst monitoring and maintaining professional standards. 28. Comply with NMC Professional Registration, practice in line with current NMC Code and keep up to date with advanced nursing practices. 29. Act as a [...] needs of the service in collaboration with the Head of Nursing. 36. To co- ordinate and monitor both Trainee and Trainer feedback to ensure continuous development of the Endoscopy training within the department. 37. To support the Endoscopy/ CDC department manager with the on- going development of the Nursing Competency based Training programme. 38. To liaise with the Head of Nursing, [...]

Job vor 13 Tagen gefunden The Royal Free Band 8a Clinical Endoscopist • London, United Kingdom, London (Greater)

MEHR

Job vor 13 Tagen gefunden Medicare EMS Group UK Ltd

Clinical Operations Manager

• Chelmsford, Essex, United Kingdom, Essex

MEHR

Job summary Medicare EMS are welcoming applications for a full- time Clinical Operations Manager for each of our frontline ambulance stations to support our contract with an NHS Ambulance Services. As part of our [...] days as required. Maintain a robust understanding of the individual scopes of practice for all grades of clinician. Assist and support the medicine management process including but not limited to the restocking of medicine bags, stock oversite, incident management, control drug audit compliance, and follow up action with the workforce when the internal processes have not been followed. Undertake patient report [...] confidentiality at all times. Ability to work as part of a multidisciplinary team and using your own initiative. High level of attention to detail and high levels of concentration. Qualifications Essential Registered paramedic with a minimum of two years post registration experience. Emergency driving qualification. Demonstrable mentoring experience. Enhanced DBS with barred list information for adults and children (on the update [...]
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Job vom 31.10.2024 Central and North West London NHS Foundation Trust Senior Clinical or Counselling Psychologist • Uxbridge, United Kingdom, London (Greater)

MEHR

[...] is adaptable and enjoys variety and working independently as well as within a team context. You will have excellent clinical skills and ideally possess supervision experience. You work alongside a range of professionals including psychiatrists, mental health nurses, social workers, drug and alcohol practitioners, experts by experience, criminal justice staff, recovery workers and group facilitators. Main duties of the job CNWL [...] effectively with this client group. You will have good research and audit skills, be familiar with care quality and clinical governance and be expected to contribute to service development in this way. You will be operationally responsible to the team manager and receive regular clinical supervision, support and reflective practice from your Professional Lead for Addictions, as well as peer support [...] Person Specification Qualifications Essential Doctoral level training in clinical psychology as accredited by the BPS, including specifically models of psychopathology, clinical psychometrics and neuropsychology, two or more distinct psychological therapies and lifespan developmental psychology as accredited by the BPS. HCPC registration Desirable CBT- p Post- graduate training in an evidence- based therapeutic technique of use to the service Post- graduate training [...]

Job vom 28.10.2024 South London and Maudsley NHS Foundation Trust

Lead Clinical Psychologist in Learning Disabilities, Autism and STOMP

• London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen

MEHR

[...] evaluation for LDA service users, as well as a track record of managing complex caseloads and engaging with multi- disciplinary clinicians and service users. A secondment opportunity is available for current SLaM and Oxleas employees provided you have your line manager s approval. Joining our team provides an exciting opportunity to actively contribute to the reduction of psychotropic drug use among individuals with learning disabilities and autism, enhancing their overall well- being. Main duties of the job If you [...] psychology or equivalent, including specifically models of psychopathology, clinical psychometrics, and neuropsychology, two or more distinct psychological therapies and lifespan developmental psychology as accredited by the BPS. Completion of further post- doctoral post- qualification specialist training including training in supervision Registration with the Health and Care Professions Council as a practitioner psychologist. Pre- qualification training and qualifications in research methodology, staff [...]
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Job vom 25.10.2024 Oxford University Hospitals NHS Foundation Trust Band 5 Senior Clinical Trials Pharmacy Technician • Oxford, United Kingdom, Oxfordshire

MEHR

[...] Pharmacy Technician- Permanent (applicants who do not meet essential criteria should still apply as post can be offered as a Band 4 to Band 5 progression position) Hello, My name is Lina and I am Clinical Trials Pharmacy Technician Team Manager for the Clinical Trials team in Oxford. I am extremely privileged to manage and support our fantastic technical team of [...] Senior Clinical Trials Pharmacy Technician in our team, you will have an extremely varied role- you will be involved in maintaining the supply chain of Clinical Trial medications to research nurses who deliver treatment to patients, maintaining financial records, completing drug accountability activities, closing down and archiving of completed studies, as well as facilitating meetings from sponsors. A successful candidate should possess: Relevant Pharmacy Technician qualification and registration with GPHC (B4 and B5) Accuracy Checking Pharmacy Technician accreditation (B5 only) Please make sure that you read both job [...]

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