Senior Director, Pharmaceutical Affairs
Senior Director, Pharmaceutical Affairs
Moderna
Paris, France
The Role:
The Sr. Director, Pharmaceutical Affairs - France will have the opportunity to lead the regulatory strategy within the local affiliate (France).
This is a newly created role intended for a forward looking, creative and agile Sr Director of Pharmaceutical Affairs able to anticipate and address the challenges involved in supporting the interactions with the regulatory authorities for the assigned region/countries for messenger RNA therapeutics as unprecedented new drug modality. The Sr Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases, Oncology, Cardiovascular and Rare diseases and, as a secondary role, will also act as the local Responsible Pharmacist (pharmacien responsable).
Their support includes but is not limited to managing the regulatory interactions with the local regulatory authority (ANSM) in France. This person will work closely with the business in the country affiliate to provide the regulatory guidance to support the overall business plans, review of promotional and non-promotional materials as well as support to market access from regulatory perspective in reimbursement/pricing discussions.
Here's What You’ll Do:
- Lead the regulatory interactions with the ANSM;
- Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in the local affiliate;
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs if needed;
- Identify and assess regulatory risks for assigned projects or programs;
- Prepare and deliver effective communications and presentations for external and internal audiences bodies, or those of any other body with executive responsibility, the company or the body, when these deliberations concern or may affect the exercise of the missions under their responsibility.
Act as Guarantor of the company's pharmaceutical operations:
- Have authority over deputy and assistant pharmacists; they approve their appointment and are consulted on their dismissal;
- Appoint the acting deputy pharmacists;
- Notify other managers of the company or organization of any obstacle or limitation to the exercise of these powers;
- Support the local business objectives and support the commercial execution from regulatory perspective (e.g. artwork review; promotional and non-promotional materials reviews; regulatory trainings and updates to the local affiliate business team; support to Market Access with regulatory documents needed for pricing/reimbursement/tenders; work closely with the Responsible Pharmacist as required per local legislation and act as Deputy etc.) Ensures the compliance of pharmaceutical activities such as those opposable on the national territory and more generally, drug safety;
- Organizes and monitors all pharmaceutical operations of the company or organization, and in particular the manufacturing, promotion (advertising and training of the medical visitation), monitoring and withdrawal of batches, distribution and storage, import and export of drugs, products;
- Has oversight over medical information and pharmacovigilance activities;
- Signs, after having read the file, the marketing authorization requests (AMM) presented by the company or body and any other request - such as requests for changes to the AMM - related to the activities that they organize and supervise;
- Ensures that the conditions of transport guarantee the good conservation, integrity and safety of these drugs, products, objects or articles;
- Watch, in the case of medicinal products intended to be placed on the market in the European Union.
Have oversight of the company's quality policy with regards to:
- The development, approval and insurance of compliance with procedures, and keeps them up to date;
- Supervision of internal and external audits;
- The design of the documentary quality assurance system;
- The development, implementation and evaluation of training programs related to pharmaceutical liability.
Here’s What You’ll Bring to the Table:
- Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD);
- 12+ years of experience in the biopharmaceutical industry. 8+ years of experience in Regulatory strategy and quality assurance/pharmaceutical affairs;
- Strong knowledge of current French regulations related to the regulatory requirements for innovative medicines, including vaccines;
- Pharmacien responsable qualification and certification;
- Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives;
- Knowledge of and experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries;
- Knowledge of the local legislation related to approval and commercialization of pharmaceutical products, including but not limited to promotional review codes and requirements etc.;
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones;
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant;
- Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned;
- Effective collaboration with to the other line functions within the local affiliate (such as general manager; commercial strategy; market access; pharmacovigilance; quality assurance etc.); proactive regulatory input and support to the local affiliate’s business activities;
- Fluency in French and English;
- A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
