Regulatory Affairs Manager - Global Pharmaceutical Company

Job Purpose
Responsible for regulatory compliance and maintenance of NAH products produced at the Dundee Scotland manufacturing facility, as well as cross functional co-ordination, and collaboration with associates in Dundee, the UK/IE and Global Regulatory teams.

Major Accountabilities
1. Responsibility for ensuring professional planning, competent RA input and maintenance of the registrations of existing UK/IE marketing authorizations produced in accordance with business needs, directions and strategies. Assists with the coordination of the technical documentation process and ensures that the required CMC documents are generated in the appropriate quality in conjunction with local RA and the Global Regulatory CMC group.
2. Ensures regulatory compliance by creating awareness of requirements and guidelines, assisting in the facilitation of timely submissions and strict participation in the local/global change control operations. Ensures regulatory compliance by timely submission of variations.
3. Advises the manufacturing facility and provides guidance/direction on regulatory matters, making recommendations and giving direction, considering current and future trends in collaboration with the UK/IE and Global Regulatory teams.
4. Participates on local cross-functional teams, providing regulatory guidance and strategy.
5. Assists in the preparation, writing, and reviewing of Part 2/CMC documents (eg, detailed and critical summaries, tabulated summaries) for post approval submissions, according to the latest regulatory requirements.
6. Participates and represents RA and NAH in various teams, trade associations, and professional organizations.
7. Applies procedures and systems necessary to maintain proper records and supporting adequate controls.
8. Performs other related duties and assignments as required by the business and directed by management.

Key requirements:
- Degree level qualification in veterinary medicine or sciences
- Experience in Regulatory Affairs or technical animal health/Pharmaceutical industry role
- Manufacturing background
- CMC experience
- GMP experience

If you are potentially interested please apply now.

hy-phen Limited is acting as an Employment Agency in relation to this vacancy.