Regulatory Affiars Manager
vor 1 Tag
Would you like to specifically demonstrate your expertise in the field of pharmaceutical services in a new professional challenge in order to fully exploit your potential? Then take the next step with us As a specialised personnel service provider, the bruederlinpartner group brings specialists and managers in the field of pharmaceuticals, research and development together with national and international companies every day. Take advantage of our personal contacts with employers throughout Switzerland
On behalf of a renowned company based in Zurich, we are looking for you in the position of Regulatory Affiars Manager.
Essential Functions
- Responsible for all aspects of regulatory submissions for an established pharmaceutical product, including major New Drug Application Supplements in electronic format per the eCTD requirements, and submissions to the FDA Office of Prescription Drug Promotion (OPDP), and other communications as necessary.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription pharmaceutical products.
- Maintains a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends.
- Responsible for the creation, and submission of new Advertisement and promotional materials to FDA’s OPDP office.
- Support the Pharmacovigilance activities to ensure compliance
- Review of Adverse Events for reportability and completing and submitting reports for Adverse Events globally as necessary.
- Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance on claims.
- Manage interactions with other functions (e.g., Quality, Medical, Legal, etc.) to ensure compliance with regulatory requirements for day-to-day operation.
- Provides support to Quality Audits (Internal or by Regulatory Authority).
- Ensure that labeling complies with all applicable regulations and guidelines
- Participate in the review of process/product changes, labeling, claims, complaints, etc.
**Qualifications**:
- 8 + years relevant pharmaceutical industry and regulatory experience
- Bachelor’s degree in science or health related field. Advanced degree preferred.
- Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations.
- Specific experience and management of the FDA OPDP process.
- Experience in Pharmacovigilance and the review and submission of Pharmaceutical Adverse Events to Regulatory agency.
- Strong knowledge of FDA regulations applicable to Pharmaceuticals, esp. 21CFR Parts 210, 211 and 800 as appropriate.
- Understanding of regulations of Medical Device/drug combination products regulation is a plus.
- Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses.
- Ability to influence and partner with cross-functional teams in a pharmaceutical organization
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
This is exactly what you are looking for as a new challenge? Please contact us - we would be very pleased to meet you and tell you more about your next dream job If you have any further questions about the vacancy, please contact Mr Robert Karsten directly on: r.karsten[at]bruederlinpartner.ch or +41 41 544 12 43
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