Regulatory Affairs Manager

Proclinical is seeking a Regulatory Affairs Manager. This role is pivotal in providing country-specific regulatory expertise and execution for the management of biotechnology products. The successful candidate will be responsible for coordinating and carrying out regulatory submissions in compliance with national regulatory requirements as well as the company's business standards. This role also involves supporting and executing local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application submissions and regulatory support for commercial activities.

Responsibilities:

• Manage regulatory affairs and local regulatory strategy for a portfolio of products.
• Ensure timely regulatory submissions that meet all regulatory requirements.
• Contribute to and execute the filing plan for their country where applicable.
• Represent regulatory on cross-functional brand or project teams and provide advice on local regulatory and compliance strategy.
• Review promotional and non-promotional materials.
• Maintain awareness of new & developing local legislation & regulatory policy and keep local management updated.
• Participate in local regulatory process improvements initiatives.
• Assist in Healthcare Compliance activities where applicable.
• Coordinate and review briefing documents and/or other submissions for meetings with Regulatory agencies.
• Collate, distribute, exchange and archive regulatory information with regulatory colleagues and give advice on local regulatory considerations.

Key Skills and Requirements:

• Relevant Bachelor's degree.
• Experience in/knowledge of developing and maintaining Clinical Trial Application (CTA) documentation in the EU.
• Knowledge and awareness of the relevant regulatory guidelines and legislation.
• Strong communication skills both oral and written.
• Organizational skills & regulatory project management skills.
• Experience within a biologics organisation (preferred).
• Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice (preferred).

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@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.