Regulatory Affairs Manager
Manager, Regulatory Affairs
South East, England - Hybrid
Albion Rye Associates are proudly partnered with a global, clinical-stage rare diseases-focused biotech company located in Cambridge, England. This position will report into the Director of Regulatory Affairs.
In this role, you will be responsible for the following, among other duties:
- Assess materials to ensure compliance with EU regulations, guidance, corporate policies, and business objectives.
- Collaborate with Commercial, Medical, and Legal teams to review and evaluate the level of clinical evidence supporting proposed claims, aligning them with product labeling and local country promotion regulations.
- Offer consistent, well-substantiated, and clear guidance to key stakeholders.
- Chair EU review meetings and coordinate related discussions.
- Partner with the Commercial team to plan and prioritize proposed promotional and disease state materials.
- Provide expert input on Regulatory strategy during early project development to commercial and other key stakeholders.
- Serve as the EU reviewer for Medical materials, including MSL materials, disease state presentations, and clinical trial materials.
- Participate in review meetings to address potential issues and escalate when necessary. Support the tracking of review process effectiveness and efficiency through metrics.
- Grasp the broader concepts within regulatory affairs and their potential organizational implications.
- Proactively identify regulatory issues and develop risk mitigation strategies.
- Act as the contact point and subject matter expert for the core promotional review process in the EU, extending coordination to country-level affiliates.
- Collaborate with US review teams for materials intended for a global audience.
To excel in this role, you should possess:
- A fundamental understanding of the pharmaceutical promotion development and review process.
- A strong knowledge of EU promotional regulations and standards.
- Exceptional interpersonal skills with the ability to communicate clearly and concisely.
- Effective written and verbal communication abilities.
- Proven skills in negotiation, influencing without formal authority, and conflict resolution.
- The capacity to work independently, take initiative, and meet deadlines.
- 2-3 years of experience in the international review and approval process for pharmaceutical/biologics promotion.
To find out more, get in touch today!
📞: 020 3148 6368