Associate Director, Regulatory & Pharmaceutical Affairs

This senior pharmaceutical and regulatory position acts as the trusted right-hand partner (“bras droit”) to the Responsible Pharmacist (RP)/Chief Pharmaceutical Officer (CPO). Working in very close collaboration with the RP/CPO, the role supports the oversight, coordination, and execution of the company’s pharmaceutical responsibilities in France and provides continuity of leadership by acting as Deputy Chief Pharmaceutical Officer when required.

The position combines regulatory affairs, pharmaceutical quality, pharmacovigilance, promotional compliance, product supply oversight, and healthcare compliance. It requires both strategic judgment and strong operational involvement to ensure that the activities of the pharmaceutical establishment—particularly those associated with the exploitant status—are conducted in accordance with French and European requirements.

As a true extension of the RP/CPO, the role is expected to anticipate issues, provide sound recommendations, coordinate sensitive matters, and take ownership of key activities. When deputising for the RP/CPO, the incumbent assumes the relevant pharmaceutical responsibilities associated with the missions set out in Article R.5124-36 of the French Public Health Code.

This position is hybrid (onsite and remote working) and will be primarily located at Alnylam France offices in Paris.

Key Responsibilities

• Participate in cross-functional regulatory initiatives within the affiliate, integrating perspectives from Commercial, Medical Affairs, Market Access, Quality, Supply Chain, Pharmacovigilance, and other relevant functions as assigned
  • Facilitate effective collaboration between Regulatory, Medical, PV, Quality, and Commercial functions to identify and address potential compliance risks and ensure timely escalation and resolution of regulatory matters.
• Provide regulatory guidance on product information, promotional and non-promotional materials, medical/scientific communications, and other company information concerning medicinal products, ensuring alignment with approved product information and applicable legal requirements.
  • Lead the regulatory review of promotional documents, as the non-promotional elements (institutional and environmental elements) to ensure that they are non-promotional working in partnership with internal groups and external Regulatory partners if necessary
• Act as the local French regulatory lead for assigned products, if necessary (ensuring local execution of the global strategy related to centralized procedure presdcription products, and/or development activities related to clinical studies etc. as needed)
• Regarding Pharmacovigilance activities, ensure local reconciliation activities, manage activities related to the approval of educational materials, and can act as LSO or LSO deputy
• Collaborate with the Responsible Pharmacist (RP)/Chief Pharmaceutical Officer (CPO) in the treatment of quality defects and any alert relating to the quality of batches, leading to a batch recall/withdrawal if necessary
• Contribute to the follow-up and processing of distribution/service complaints in concertation with the supply chain
• Supervise the monitoring of supplies of marketed products to ensure appropriate and continuous supply
• Contribute to the evaluation of product quality reviews (PQR) and ensure the follow-up of corrective and preventive measures described in the PQR and related to the performance of the manufacturing process and the storage conditions of the products
• Manage the implementation of process reviews and the pharmaceutical quality management system (QMS) in order to respond to regulatory changes and contribute to the operations inherent to the business
• Support activities regarding the Chart for promotional information, audit of subcontractors
• Support activities regarding compliance or relations with Healthcare Professionals and anti-gift law
• Build and maintain strong partnerships with external consultants, CROs, regulatory service providers, industry stakeholders, and relevant authorities to advance regulatory objectives and ensure appropriate local regulatory compliance.
• As a Chief Pharmaceutical Officer Deputy, ensures compliance of the missions as described in art. R.5124-36 of the French Public Health Code when acting to replace the RP/CPO

Qualifications

Required

• PharmD with relevant experience registered with “Ordre des Pharmaciens” (section B)
• Extensive knowledge and at least 7 years of experience of country-specific French/European Regulatory requirements for innovative products in late-stage development and post-approval
• Sound knowledge and experience of French and European Regulatory Affairs and associated requirements, specifically with prescription medicines and Centralized procedure
• Prior relevant knowledge and experience related to the activities related to the “exploitant”
• Established knowledge and at least 5 years of experience in promotional activities and capabilities to intecact with the medical affairs and marketing/commercial teams, as well as the French Competent Authorities
• Experience with working closely with ANSM and an excellent track record of building relationships with and influencing Regulatory Agencies
• Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
• Role entails particularly close and continuous collaboration with the RP/CPO, built on trust, transparency, responsiveness, and a shared understanding of priorities and risks.

Preferred

• Solid knowledge and at least 3 years of experience of country-specific French/European Regulatory requirements for pharmacovigilance
• Knowledge of the compassionate use programs and releated regulatory requirements in France
• Experience in Quality Assurance and QA operational activities (e.g. managing deviations, changes, complaints, issues, recalls etc.), in managing third parties including auditing and contract management, in managing inspections by competent authorities

Chez Alnylam, nous sommes engagés en faveur d’un processus de recrutement inclusif et de l’égalité des chances. Nous veillons à créer un environnement de travail dans lequel chacun peut se sentir pleinement intégré, exprimer son authenticité et développer tout son potentiel. Conformément à la réglementation, tous nos postes sont ouverts aux travailleurs en situation de handicap. Si vous avez besoin d’un aménagement spécifique dans le cadre du processus de recrutement, notamment pour l’entretien, n’hésitez pas à nous en faire part.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

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