Regulatory Affairs Manager

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.