Director, Regulatory Affairs
The Regulatory Head for France is responsible for working with local Regulatory Authorities and other stakeholders to ensure that the company complies with country’s applicable legislations and regulations pertaining to our portfolio (at all stages of the product’s life cycle) i.e. ensure that Gilead medicinal products can be:
- maintained on the market.
Essential Duties and Responsibilities
Core Technical Regulatory Contributions:
Interaction with Local Health Authorities (ANSM mainly)
Leads interaction and communications with ANSM and acts as the main point of contact.
This includes (not exhaustive):
- Works proactively to build and maintain contacts with relevant local ANSM personnel;
- Leads interactions with other departments/functions for response to local HAs;
- National Scientific Advice and pre-submission meeting preparation and follow-up;
- Management of inspections;
- Quality defects/falsified or counterfeit products/batch recall management;
- Out of stock situation management;
- Management of, or support for incidents involving regulatory matters (as required);
- Dear Healthcare Provider Communications submissions and follow-up until approval;
- Risk Minimization Measures submissions and follow-up until approval.
Ensure that all regulatory submissions to local HAs are done in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) and country.
Main types of submissions are (not-exhaustive):
- Clinical trials applications, amendments and other clinical trials submissions;
- Compassionate Use & Early Access applications;
- Marketing Authorisation (MA) applications;
- Variations and other MA maintenance applications;
- Import permits;
- Risk Minimization Activities materials;
- Dear Health Care Professional communication;
- Promotional materials.
Local Statutory Responsibilities and Liabilities
Ensure that Gilead fulfills all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.
- Act as the local Gilead representative as required by national law;
- Acts as the Deputy/Chief Pharmaceutical Officer (CPO)/Qualified Person according to French law, and to the Promotion Charter and carries out the corresponding duties: promotion, medical information, pharmacovigilance, batch follow-up and recall, distribution. Contributes to the Health Authority Inspection, and supervises the “Certification of the reps”;
- Collaborates with the Pharmacovigilance Responsible person and her/his deputy.
Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead
- Ensure compliance with local law and regulation and consistency with global procedural documents;
- Lead the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP/GDP, GPvP and GCP and the Promotion Charter;
- Manage Local Regulatory Audits and Regulatory Compliance audit within affiliate and assure that the General Manager and other departments are aware and support the process;
- Maintain GDP license in the country, as required and set up internal and 3PL audits management as appropriate;
- Ensure the establishment of Quality Agreement where required including with DSPH, GSIUC and with 3PL;
- Promotional material review and approval, submission to HA if applicable;
- Ensure compliant labeling for Gilead medicinal products in the country (SmPC, PIL, packaging) and manage timely updates;
- Appoints the Local Coordinator for GDocs/GxPLearn.
Input into Development
Provide input to the global regulatory product strategy, upon request.
Share with International Regulatory Affairs (Int RA)/development teams knowledge on:
- HA expertise, expectations and requirements;
- National scientific advice relevance and requirements;
- Regulatory Authority contact profiling;
- Manage negotiations with local HAs with regards to development products eg questions on clinical trial applications.
- Closely monitor and report all external relevant changes to concerned stakeholders within the company at local and global level. That applies for local requirements to be explained at the local and International level but also for changes or new information at International level affecting affiliates;
- Monitor competitor regulatory information such as approvals, changes in label and other relevant local details. If applicable, Regulatory Affairs (RA) contributes to relevant local guidelines and regulations’ development that impact Gilead, identifying trends and changes that may impact on the company;
- Anticipates potential challenges in registration and changes in health care policies that could impact Gilead and develop strategies to optimize the outcome;
- Maintains up to date knowledge of highly complex regulatory requirements, contributes to preparation of new local regulatory guidance when applicable, comments on draft regulatory guidance and communicates changes in regulatory information to Int RA;
- Participates in industry trade groups and regulatory affairs professional societies.
Management and Leadership
- Provide the Vision and Direction for the RA organization at the country level in line with global RA and the local Affiliate Visions;
- Serves as a core member of the country leadership team as the representative of R&D;
- Leads the country regulatory team and serves as a core member on the International Regulatory Heads’ fora;
- Sets clear goals and objectives in line with the global RA strategy;
- Actively participates in internal and external working groups;
- Leads and/or represent RA within cross-functional and/or cross-regional regulatory sub-teams;
- Plan, monitor, allocate and optimize resources and budget with regards to portfolio evolution as well as regulatory changes;
- Ensure a sufficiently staffed and adequately trained RA department;
- Develop local RA team with clear succession plans for critical roles.
Key Differentiating Responsibilities/Contributions
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory;
- Ensure optimum execution of Int RA registration strategies and plans with multiple functional areas in the country;
- Establishes and maintains good and strong relationships with all functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc) and with Gilead Sciences Int RA in order to ensure the success of local and international business results from the regulatory point of view;
- Takes a leadership role in conducting risk assessments on major local regulatory issues;
- Take the leadership role in updating and preparing the Company for major changes in regulatory legislation in the country;
- Decision Making: Makes important decisions that impact the department and ensure appropriate communication;
- Plays an active role in industry organizations building recognition as a thought leader, as required locally if appropriate;
- Initiates or contributes to local and/or global process improvements which have a significant impact on Gilead;
- Represents Regulatory Function at internal meetings.
Professional Experience/Key Skills
- Typically requires a Pharmacist Degree and a Masters in Pharmaceutical Sciences or equivalent discipline and substantial, relevant experience in regulatory affairs. An advanced degree is desirable;
- Extensive experience in and understanding of role of RA and regulatory requirements in Pharmaceutical/Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local;
- Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities;
- Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function and in the affiliate;
- Previous people management experience if needed and direct experience working with Regulatory Authorities essential;
- Excellent decision making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated;
- Excellent verbal, written, organization skills and interpersonal communication skills.