Website Achieva Group Limited
An excellent opportunity has arisen for a Senior Regulatory Affairs Consultant to join my client, a large biotech based in London. This role sits within their oncology department and the ideal person will have a strong background within full lifecycle regulatory affairs; CTAs through to registration and post approval.
Responsibilities include:
- Regulatory management and local regulatory strategy for a portfolio of products
- Ensure regulatory submissions are timely and meet the clients corporate and local 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 at a local or regional level
- Review promotional and non-promotional materials
- Maintain an awareness of and ensure local management are kept up to date on new & developing local legislation & regulatory policy
- Disseminate relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Assist locally in Healthcare Compliance activities where applicable
- Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
- Collate, distribute, exchange and archive regulatory information with regulatory colleagues and the affiliate and provide advice on local regulatory considerations in a timely manner.
Basic qualifications:
- Relevant Bachelor’s degree is essential
- Experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
- Knowledge and awareness of the relevant regulatory guidelines and legislation
- Strong communication skills both oral and written
- Organizational skills & regulatory project management skill
Preferred Qualifications and Experience:
- Experience gained within a biologics organisation
- Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice
For further details, please contact Tim Barratt on 01727 817 626 or email tbarratt@achieva.co.uk