Senior / Consultant - Regulatory Affairs - Global Consultancy- Friendly environment- Perm role - Buckinghamshire / Part remote working
You are a source of expertise in the registration and post-licensing activities of pharmaceutical products or other health products.
Registration (e.g. coordination of EU procedures, responses to questions, experience with export countries)
Post MAA (e.g. preparation and submission of variations, advice on classification and documentation required, MA holder transfers, renewals, PSUSA)
Supports the regulatory local launch activities at global level and early access program (set up the regulatory launch strategy, coordinates local partners, compiles local requirements).
Global regulatory promotional materials review & validation: reviews and validates promotional materials from a regulatory point of view as per EFPIA/IFPIA guidelines, coordinates partners
Writing of regulatory documents
Interaction with agencies and partners
Conducts due diligence on the regulatory part of dossier/company
If possible, you are also experienced in development and regulatory strategy (e.g. scientific Advice, ODD, PIP, CTA)
You ensure high quality and on time delivery to clients to maintain client satisfaction.
Education and experience
• A least 7 to 10 years' experience in the pharmaceutical industry, broadly based Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe and/or at export.