Regulatory Affairs Senior Specialist

Job Description

The Position

The Regulatory Affairs Senior Specialist is in charge of the regulatory affairs of a product range.

Depending on the team organization, the following tasks may also be part of the role:

• support to other European countries (acting as SME)
• management of quality and compliance of RA activities.

Responsibilities

• Regulatory management of a range of products for France and, depending on team organization, as support to other european countries (acting as SME)
• Additional potential role: CRA-lead
• Regulatory management of a range of products for France and, depending on team organization, as support to other european countries (acting as SME)
• Contribute to obtaining MAs in the required time by defining the technical-regulatory strategy and working closely with internal interlocutors, including RAE
• Organize the implementation and monitoring of Risk Management Plans (RMPs), Risk Minimization Measures (RMM) and Additional Risk Minimization Measures (ARMM)
• Manage existing MAs by filing applications for variation, renewal or extensions of indications on time
• Analyze and evaluate potential risks related to the life cycle of drugs
• Ensure the translations of the annexes of the MA and the preparation of packaging articles in compliance with the criteria of accuracy, conformity and deadlines.
• Regulatory and competitive intelligence : monitor the latest submissions for company's pipeline competitor, applicable local and European regulations and directives; relevant regulatory and scientific news (monitoring), carry out critical analysis of texts and inform the persons concerned in an appropriate manner.
• Establish and maintain privileged relationships with the main players in the regulatory environment (ANSM); develop relevant arguments to negotiate with and convince the Health Authorities,
• Design and implement ad hoc local regulatory action plans, as required.
• Contribute to the review of the transparency file and / or the definition of the strategy of the presentations for possible hearings before the Transparency Commission.
• Ensure the transmission to the departments concerned (medical affairs, market access, pharmacovigilance, quality assurance, production, legal, marketing, ...) of regulatory information and adopt an advisory posture on its field of regulatory expertise.
• Prepare, have validated by the Responsible Pharmacist and submit annually the Shortage Management Plans (PGP) for Drugs of Major Therapeutic Interest (MITM)

Compliance

• Preparation and management of Local Product’s SmPCs, PIL, mandatory info intended to physicians, packaging materials and other applicable regulatory documents in a timely manner and in accordance with Organon's standards, local requirements and packaging material management procedures.
• Ensure the dissemination of mandatory information within the deadlines of compliance.
• Transmission of the necessary information regarding the regulatory status of the products for which he/she is responsible to all internal customers.
• Ensure the proper use of GLAMS to generate packaging items and implement changes thereto.
• Ensure effective and consistent implementation and use of internal and external regulatory systems and databases.
• Ensure the updating and completeness of regulatory files and archives.
• Participation in the creation and management of standard operating procedures necessary to ensure compliance with current regulations.

Additional potential role:

• CRA-lead

Act as country regulatory affairs lead for EU procedure : preparation, management and submission of the related variation. 

Required Education, Experience, and Skills 

• Rigor
• Good knowledge of regulatory procedures
• Good knowledge of processes and regulatory tools / databases specific to Organon
• Ability to organize and manage priorities
• Negotiation and communication skills, focus on results
• Knowledge of computer tools
• Team spirit
• Fluent English (written and oral) required
• Knowledge of regulatory cases, particularly European and French
• Know how to manage and motivate your employees
• Be creative and master problem solving
• Know the professional environment and know how to work in a team
• Communication skills
• Experience in Regulatory Affairs (3 years minimum), including in direct relation with the ANSM
• Degree in Pharmacy and Master in Regulatory Affairs or equivalent (DEA biology...).

Secondary Job Description

Who We Are:

Organon delive