SeniorFull TimeEN
Stragen is an international pharmaceutical group specialized in the development, manufacturing, and commercialization of specialty medicines. Operating across multiple countries, Stragen combines an entrepreneurial culture with strong governance, quality standards, and regulatory compliance in a highly regulated environment.
Reporting to the Head of Regulatory, the Regulatory Affairs Pharmacist Management and coordination of EU and worldwide registration of dedicated products from initial Marketing Authorization Applications over full life cycle.
Key Responsibilities :
- Management and coordination of EU and worldwide registration of dedicated products from initial Marketing Authorization Applications over life cycle
- Define regulatory strategies
- Accountable for all information presented in module 1 and dossier compilations
- Take in charge module 3 sections writing, when needed
- Interact with other departments, customers, manufacturers and experts to obtain required documentation and materials in duly-time
- Ensure that deadlines are met by preventing and identifying issues that may delay submission / approval
- Reply to Health authorities’ regulatory deficiencies
- Follow-up post-approval activities (variations, renewal…) within the required timelines and in accordance with the regulatory requirements
- Ensure submission process and standards adhere to internal SOPs
- Prepare and submit translations of Product information in France and other European countries
- Approve and follow up the SmPCs, texts of packaging items and legal notices, when necessary
- Review promotional material in line with applicable rules, when necessary
- Review of regulatory sections of PQRs
- Accountable for timely and liable maintenance of internal and external databases
- Communicate outside the organisation on behalf of the company with Health Authorities and Customers; ensure that relevant information is shared internally
- Represent the regulatory function in project teams
- Manage regulatory consultants, when needed
- Continuously challenge workflows and procedures with regards to improvement of personal /team performance
- Maintain awareness of current and new regulatory legislation/guidance and ensure compliance with these requirements
- Participate in inspections, internal and external audits, as required
- Perform other duties as assigned by the Head of Department
Requirements
- Detail-oriented
- Well-organised; able to judge on time required to complete a task in order to respect given timelines
- Strong analytical /problem solving skills
- Team spirit, strong communication /organisational and interpersonal skills
- Keen on working in an international environment within a fast-growing company
- Able to work in a multicultural environment
- Strong knowledge of EU pharmaceutical regulations,
- Knowledge of other regions pharmaceutical regulations, as appropriate,
- Fluent in English, a good proficiency in French or any other EU language is a plus,
- Good command with Word and Excel. Experience with document and submission management tools.
Qualifications :
- PharmD or Scientific B Sc with a Regulatory Affairs specialisation
- 3 years+ of experience in Regulatory Affairs within Pharmaceutical Industry, preferably on small molecules and/or generics and/or biosimilars.
