Associate Director, Regulatory & Pharmaceutical Affairs (Chief Pharmaceutical Officer Deputy)

<p>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.</p> <p>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.</p> <p>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.</p> <p>This position is hybrid (onsite and remote working) and will be primarily located at Alnylam France offices in Paris.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Participate in cross-functional&nbsp;regulatory initiatives&nbsp;within the affiliate, integrating perspectives&nbsp;from&nbsp;Commercial, Medical Affairs, Market Access, Quality, Supply Chain, Pharmacovigilance, and other relevant&nbsp;functions as assigned <ul> <li>Facilitate effective collaboration&nbsp;between&nbsp;Regulatory, Medical, PV, Quality, and Commercial&nbsp;functions to identify&nbsp;and address potential&nbsp;compliance&nbsp;risks and ensure&nbsp;timely escalation and&nbsp;resolution of regulatory&nbsp;matters.</li> </ul> </li> <li>Provide regulatory guidance on&nbsp;product information, promotional&nbsp;and non-promotional&nbsp;materials, medical/scientific&nbsp;communications, and other&nbsp;company information concerning&nbsp;medicinal products, ensuring alignment with&nbsp;approved product information&nbsp;and applicable legal&nbsp;requirements. <ul> <li>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</li> </ul> </li> <li>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)</li> <li>Regarding Pharmacovigilance activities, ensure local reconciliation activities, manage activities related to the approval of educational materials, and can act as LSO or LSO deputy</li> <li>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</li> <li>Contribute to the follow-up and processing of distribution/service complaints in concertation with the supply chain</li> <li>Supervise the monitoring of supplies of marketed products to ensure appropriate and continuous supply</li> <li>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</li> <li>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</li> <li>Support activities regarding the Chart for promotional information, audit of subcontractors</li> <li>Support activities regarding compliance or relations with Healthcare Professionals and anti-gift law</li> <li>Build and maintain&nbsp;strong partnerships with&nbsp;external consultants, CROs, regulatory service providers, industry stakeholders,&nbsp;and relevant authorities&nbsp;to advance regulatory&nbsp;objectives and ensure&nbsp;appropriate local&nbsp;regulatory compliance.</li> <li>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</li> <li>Promote a&nbsp;culture of&nbsp;regulatory compliance, transparency, and responsible communication&nbsp;of medicinal-product&nbsp;information&nbsp;across the affiliate</li> </ul> <p><strong>Qualifications</strong></p> <p>Required</p> <ul> <li>PharmD with relevant experience registered with “Ordre des Pharmaciens” (section B)</li> <li>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</li> <li>Sound knowledge and experience of French and European Regulatory Affairs and associated requirements, specifically with prescription medicines and Centralized procedure</li> <li>Prior relevant knowledge and experience related to the activities related to the “exploitant”</li> <li>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</li> <li>Experience with working closely with ANSM and an excellent track record of building relationships with and influencing Regulatory Agencies</li> <li>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