Associate Director, Regulatory Affairs Alzheimer's
- Maidenhead, United Kingdom
As an Associate Director within Development Sciences, you will be responsible for the EU+ regional development strategy in the Alzheimer’s disease area, in alignment with the EU+ business strategy.
Key responsibilities for this role will be:
· Responsible for defining and implementing EU+ regional regulatory strategies, including filing of regulatory submissions for assigned programs
· Responsible for leading and/or oversight of the planning, coordination and preparation of regulatory submissions
· Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
· Secure alignment across functions
Direct the organization and preparation of clear and effective submissions
60% Responsible for defining/developing and implementing innovative regional regulatory strategies, including filing of all appropriate regulatory submissions e.g. MAAs, PIPs, ODDs. Lead health authority meetings (Scientific advice, PIP clarification, Rapporteur meetings, Pre-submission, oral explanation, SAG etc.).
10% Identify and assess regulatory risks associated with assigned projects and overall product development. Defining strategies to mitigate risks.
20% Provide leadership on project teams and subcommittees in all areas of regulatory science. Provide input to Regulatory Senior Management teams and regulatory guidance to company personnel.
5% Influence key stakeholders in multiple departments at all levels. Interact with a wide variety of outside contacts (including consultants/ contractors, corporate partners and regulatory agency personnel).
5% Autonomously represent the company with local and regional regulatory authorities, contractors and corporate partners
• 8-10 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 5 years in Regulatory Sciences.
• EU regulatory experience managing development programs preferred.
• Experience in interpretation of regulations, guidelines and policy statements.
• Experience and knowledge in the preparation of regulatory submissions and involvement in regulatory authority meetings.
Minimum Education Requirements
• BA/BS/University degree required, Life/Health Sciences preferred.
Back to top