Senior Regulatory Affairs Manager
Posted on Aug 30, 2019 by Stamford Consultants AG
- Support submissions, through from planning to review - including scientific advice meeting packages, MAA, amendments, variations, annual reports etc.
- Represent regulatory in cross-functional discussion and present issues accordingly, where appropriate.
- Provide guidance to teams in support of regulatory activities for International markets.
- Participate in activities related to meetings with Health Authorities including preparation and coordination's of Briefing packages.
- Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project team.
- Provide insight and guidance on implementation of regulations with respect to the preparation and submission of regulatory documentation as well as the design of clinical trials.
- Create regulatory submission timelines in collaboration with cross functional teams.
- Provide input into regulatory development plan.
- Maintains regulatory compliance of OD, PIP, and MAA.
- Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
- Fluent English required (oral and written)
- Good skills in site (local) language desired (oral)
- Regulatory experience in drug/biopharmaceuticals
- MAA filing experience
- Orphan Drug and PIP experience
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
- Strong experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Effective planning, organizational and interpersonal skills.
- Reasonable approach to risk assessment.
- Excellent written/spoken communication and negotiation skills.
- Computer literacy.
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