Senior Regulatory Affairs Manager

TITLE:Senior Regulatory Affairs ManagerJob Title: Senior Regulatory Affairs ManagerManager: Head Regulatory Affairs MOWPlace: FranceSUMMARYAs a Regulatory Affairs manager for Indivior France SAS, suggest and implement the technical and regulatory strategy to ensure the implementation of operations for the registration, manufacture and sale of Indivior's products. Perform all activities related to the registration and maintenance of marketing authorizations (MA), management of CMO to manufacture and release products, and for the sale of such products in compliance with regulations for France and Germany.This position is responsible for ensuring that regulatory affairs, quality assurance, pharmacovigilance and compliance activities related to Indivior products comply with local government regulations in France and Germany. This position is the contact point with health authorities.In addition to the position described in the Function Profile, the Regulatory Affairs Manager shall act as Indivior France SAS Responsible Pharmacist, within the meaning of Article R of the French Public Health Code, and comply with Articles R to R , R , R , and R of the same Code, pursuant to its designation and its mandate. The position described in the Function Profile shall be distinguished from the above-mentioned position of Responsible Pharmacist.SCOPE OF THE FUNCTIONThe position is to :< >Carry out the necessary activities of an entity which is to become the Marketing Authorization Holder (MAH) and "exploitant" in France within the meaning of Article R of the French Public Health Code, namely procuring the manufacture and release of narcotic products by CMO, and subsequent sale of products in France and Germany together with the responsibility for providing guidance for, and management of regulatory activities related to lndivior with health authorities and local government regulations in France and Germany.< >Provide regulatory strategy for company projects and ensure the implementation of drug regulation for the registration and sale of products.< >Ensure the implementation of appropriate quality system in collaboration with Indivior Global Quality team and local requirements.< >Be responsible for ensuring the effectiveness of Indivior's compliance with pharmacovigilance regulations as well as the management of pharmacovigilance service providers if the operational implementation of pharmacovigilance is delegated to the latter, in France and Germany. The position will work with EU QPPV expected to be an external consultant.RESPONSIBILITIES< >Support management team to manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorizations (MAs), and appropriate licenses/authorizations.< >Support all activities to update Mock-ups and Artwork according to the valid SOPs and Work instructions in force.< >Liaise directly with local health authorities to develop and lead regulatory strategies for products portfolio in line with global strategic plans. Ensure the registration and regulatory compliance of local products. Amend registration dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favorable labelling and claims.< >Monitor and interpret local regulatory issues and trends that will impact the products and ensure that the company is aware of significant regulatory issues. Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, clinical, labelling, product information and production of our products.< >Represent company interests with local government agencies industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products.< >Maintain database of local regulatory requirements accessible to the global team.< >Provide technical support to respond to consumer and legal inquiries on regulatory issues for our products. Report measures of product registration and regulatory compliance performance. Assist with local statutory reporting requirements. Provide regulatory documentation required by other functions or Indivior businesses< >Write, review and update the SOP related to the Regulatory Affairs activities and ensure compliance with required regulations (including Sunshine reporting requirements).Ensure that Medical Information, Product Quality Complaint processes and pharmacovigilance organization meet local regulationsReview and update the local documents related to the Risk Minimization Measures.Provide support for Compliance activitiesKEY CHALLENGESEstablishing and maintaining Indivior France SAS as an entity which procures and manages manufacture of narcotic products by CMO, and subsequent sale of products in France and Germany). < >Maintaining SOPs and process, and managing audits from relevant regulatory authorities, as required to enable such operations.Possessing a strong knowledge and understanding of pharmaceutical regulations concerning the narcotic drug business in France and Germany. Thorough familiarity with the process of obtaining and maintenance of pharmaceutical MA approvals & narcotics licenses, MA variations, and PSUR reporting in France and Germany.Possessing strong reasoning ability to support and prioritize projects, adapt to shifting priorities, and resolve problems/conflicts. Skill at research, logic, objectivity, and good judgement, as necessary, to formulate supportable opinions rapidly.Managing the production of necessary regulatory and technical documentation to meet the exacting demands of regulatory authorities.Meeting regulatory and project deadlines in a performance-driven environment.Dealing with changes that require regulatory action with the added complexity of controlled ethical drug products, and socio-politically sensitive indications and therapeutic areas.Articulating technically sound scientific/regulatory principles that support best practices.Dealing with Indivior Global ensuring that organisations comply with their local regulation, mainly for Medical Information, Pharmacovigilance and Quality Assurance in France. Alert Indivior Global if processes are not compliant with local regulations.EXPERIENCE / PROFESSIONNAL QUALIFICATIONS< >Advanced degree in Pharmacy< >A minimum of 10 years' experience in Regulatory Affairs is required.< >Working knowledge of key health authorities in EU.< >Experience in narcotic pharmaceutical business is preferred.< >Experience in narcotic pharmaceutical business is preferred.CARACTERISTICS< >Result oriented, entrepreneurial, and self-motivating.Hands-on with executional focus.Leadership and interpersonal skills capable of building strong working relationships with a collaborative style. Intellectual sensitivity and strategic thinking, that ensures the patient is held at the center of business plans and actions.Strong ability to review & see beyond the detail of the numbers and identify issues and opportunities in the business.Strong patient focus balanced with commercial understanding of business issues/opportunities.Effective communication skills, both written and oral (in English).