Regulatory Affairs Director
An amazing opportunity has arisen for a Regulatory Affairs Director to join a global pharmaceutical company based in Cambridge. This role is specifically working with emerging markets and would be the best way to establish your career at a national company.
- Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures.
- Lead the objective assessment of emerging data against aspirations and update senior management in Regulatory and International Commercial on project risks/mitigation activities.
- Serves as the single point of contact and Regional Regulatory Affairs representative on Regional Product Teams
- Leads the planning and construction of the International dossier
- Regional RAD is accountable for interacting with the regional commercial and cross-functional teams to ensure business needs are understood within the GRST and to ensure regional commercial engagement with the proposed regulatory strategies/risks/mitigation plans.
- Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. (GRL accountability in close collaboration with Regional RAD).
- Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
- Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Proactively contributes across RAD community and/or across Regulatory Excellence objectives and activities.
Skills and Requirements
- Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
- More than 7 years of experience or equivalent of regulatory drug development including product approval/launch.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.