Proclinical is seeking a dedicated Regulatory Affairs Manager. This role involves supporting multiple products from a global and international regulatory perspective. The successful candidate will be responsible for generating country-specific regulatory strategies, interfacing with affiliate offices, and ensuring regional issues impacting global regulatory strategy are considered and addressed.
Responsibilities:
- Generate country-specific regulatory strategies and provide feedback to internal teams regarding submission plans.
- Interface with affiliate offices for strategies or activities that impact a specific country.
- Ensure regional issues impacting global regulatory strategy for proposed filings are considered, with risks identified and appropriate contingency strategies in place.
- Review the preparation of M2 and 3 CMC components of filings and assess their suitability for submission in the relevant countries.
- Manage strategy and execution for all regulatory CMC submissions in compliance with global filing plans and local regulatory requirements.
- Author and coordinate responses to questions across assigned products and countries.
- Communicate regional needs for ensuring reliability of the supply chain and successful launch in collaboration with relevant regional stakeholders.
- Provide guidance for regulatory assessments of change control requests.
- Set project timeframes and priorities based on project objectives and ongoing assignments.
- Gather, consolidate and analyse regulatory intelligence for International Markets and support its application to product-specific activities.
- Share regulatory information and implications with stakeholders on an ongoing basis and provide advice on regional considerations.
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the products.
Key Skills and Requirements:
- Strong understanding of global and international regulatory perspectives.
- Ability to generate and implement regulatory strategies.
- Excellent communication and coordination skills.
- Ability to manage multiple projects and priorities.
- Knowledge of legislation, regulatory policy, and technical Regulatory guidance.
Interested or know someone who might be? Reach out to using the following:
✉️ p.duvall@proclinical.com
📞 0203 0789 542 (5319)
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. is acting as an Employment Agency in relation to this vacancy.
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