Regulatory Affairs Manager

Regulatory Affairs Manager

Manager, Regulatory Affairs

South East, England - Hybrid

Full-time, Permanent

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.

Responsibilities:

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.

Qualifications:

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

📧: george.creed@albionryeassociates.com