Associate Director – European Ad/Promo Regulatory Affairs
2 days left
- Experience Level
- Experienced (non-manager)
RBW Consulting are working on behalf of a biotechnology company in their search for an Associate Director, to work on Regulatory Affairs for Advertising and Promotion.
This role is responsible for providing regulatory support and guidance for assigned products and disease state communications for product development programs, from both a strategic and tactical perspective.
Working alongside cross-functional teams, the successful candidate will oversee regulatory aspects of review and approval of international communications and activities to ensure compliance with applicable regulatory requirements.
Duties & Responsibilities:
- Utilises their expert knowledge of EU regulations governing product promotion and related communications, including pipeline and disease state communications
- Provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications
- Assesses the regulatory context and provides interpretations of applicable codes, regulations, guidance or regulatory precedents, including requirements related to submission of materials to relevant authorities.
- Provides guidance and input for the development of products reflective of promotional considerations
- Provides direction and works collaboratively to ensure that changes in product labelling are carried into promotional materials in accordance with company procedures and regulatory requirements
- Prepares and executes training of relevant stakeholders
- Collaborates in cross-functional efforts with Medical, Legal and Commercial functions to develop and update procedures and guidelines
Skill and Qualification Requirements:
- Bachelor’s or Advanced degree in relevant scientific discipline
- Experience in regulatory ad/promo within a pharma or biotech business.
- Thorough knowledge of international codes, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs/biologics and investigational treatments
- In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims
- Strong interpersonal and communication skills with demonstrated ability to communicate difficult concepts and persuade others
- A strong problem solver, with the ability to innovate, analyse and solve problems
This is a fantastic opportunity to join a leading biotech in a challenging role and will be rewarded with a very generous remuneration and benefits package. Initially working from home due to government guidelines, the view is for the role to be combination based from home and their Central London office.
If you are keen to learn more about this opportunity, then please apply today so that Katie Dunbar at RBW Consulting can review your profile and be in touch to discuss this in more detail.
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