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Senior Manager Regulatory Affairs
- Permanent
- Senior/Director & VP, Project Manager, CMC
- United States
Senior Manager Regulatory Affairs - Remote - Permanent
Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candidates.
Primary Responsibilities:
The successful candidate will be responsible for supporting regulatory strategy, systems, processes, submissions, and health authority interactions. This role requires close collaboration with cross-functional team members within the company.
Skills & Requirements:
- In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and StartingPoint templates).
- Strong communication and collaboration skills.
- Experience in regulatory affairs within the pharmaceutical/biotechnology industry.
The Senior Manager will:
- Support the implementation of the regional regulatory strategy and regulatory submission plans in line with business objectives.
- Facilitate tactical implementation at the regional level and contribute to effective communications with regional and global teams on product activities and issues.
- Participate in the preparation for meetings with regional regulatory agencies.
- Support communications with FDA in support of submissions.
- Prepare, review, and provide input on documents for submission to regional regulatory agencies.
- Collaborate with regulatory team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc. to ensure timely delivery of submission components.
- Maintain current IND, ODD, and NDA submissions by ensuring timely and appropriate submission of required information within eCTD sequence as well as maintaining logs.
- Contribute to the management of product lifecycle submissions (e.g., DSURs, IBs).
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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