Associate Director Regulatory Affairs .

Job omschrijving.

• Lead regulatory activities for major projects and participate in multidisciplinary project teams
• compile required CMC documents (i.e. author, review and collect documentation) in compliance with EU and US regulations and guidelines, to support the technical content of regulatory submissions.
• Contribute (author, review and provide scientific input) in building a strategic development plan by providing the regulatory perspective  and advise on risk-based approaches.
• Develop and execute well-defined and defensible regulatory strategies, for European, U.S. and national submissions, in order to accomplish customer’s regulatory and business objectives in an efficient and timely manner.
• Prepare and conduct regulatory meetings with health authorities, e.g. scientific advice, pre-submission or protocol assistance meetings.
• Contribute to the development of regulatory risk management recommendations and decisions.
• Set forth the impact (implications and consequences) and benefit-risk  that emerge from proposed regulatory recommendations.
• Identify, analyse and interpret relevant law, regulations, and guidance documents covering regulatory requirements for pharmaceutical products and drug-device combination products (in development and/or registered products) and recognize potential regulatory issues, solutions, and opportunities.
• Analyse communications from health authorities and respond appropriately.
• Perform due diligence and regulatory gap analyses on candidate CMC development products and deliver advice how to reach critical CMC-RA development milestones.
• Review documentation from stakeholders for regulatory purposes and indicate the regulatory implications of the analysis.
• Contribute to the development of new or revised legislations and guidance documents and advocate SPS’ organizational position to decision-makers.
• assess regulatory needs for post-marketing submissions
• Participate in lifecycle management activities.

Profiel van de kandidaat.

Required:

• A Master’s degree in biological, pharmaceutical, chemical or engineering sciences is preferred.
• A minimum of 8-10 years of experience in the regulatory field, including relevant and demonstrable experience with drug products, combination products and/or medical devices is required.
• Direct and significant (8-10 years) experience in writing CMC documentation for INDs, ANDAs, NDAs and/or MAAs.
• In depth knowledge of ICH, EMA and FDA regulations and guidance on drug products and/or drug-device combination products.
• Direct experience in orchestrating and leading meetings with Health Authorities (EMA and/or FDA)
• Advanced knowledge of the pharmaceutical drug development process.
• Basic knowledge of how QbD principles can be applied in design space and further in the regulatory framework. 
• Direct experience in developing regulatory strategies in compliance with regulatory requirements.
• In-depth knowledge of the registration procedures for drug and drug-device combination products in Europe and the US.

Skills:

• Customer focussed.
• Team worker.
• Effective technical and regulatory writing skills to author regulatory CMC documents and reports.
• Fluid intelligence - ability to solve problems in novel domains with no previous knowledge.
• Ability to find effective solutions to deal with complex matters.
• Effective English oral and written communication skills to establish, maintain and further professional collaborative relationships with clients and other stakeholders.
• Ability to transfer information about complex technical regulatory issues clearly and in plain language to internal and external stakeholders.
• Ability to work autonomously, recognizing when to seek input and communicate effectively within a multi-disciplinary team.
• Multi-tasking skills – ability to set priorities and efficiently manage and deliver multiple projects simultaneously.
• Commitment to personal development.