In the context of a new opportunity, our client, an international pharmaceutical group, is looking for its new Regulatory Affairs Specialist.
The specialist will ensure regulatory compliance and delivery of the local regulatory milestones for the assigned range of products of the Company portfolio (from early development to Marketing Authorization submission and post-licensing activities):
- Ensure compliance on Promotional activities in line with the legislation and with the Company procedures to support Business units' projects.
- Contribute actively to the RA strategy of the company
- Ensure an EU role to support Global Regulatory Affairs in EU regulatory activities
Tasks and responsibilities:
Ensure local regulatory compliance with the Company procedures and in line with the French legislation by:
- Taking in charge promotional activities for the assigned range of products:
- By reviewing the promotional campaign along the process and ensuring regulatory compliance to avoid rejections from the health authorities
- By coordinating submission of the dossiers to the Health Authorities and following the approval/rejections
- By advising Business Units on regulatory aspects that are importance for their activities.
- By taking part actively in handling potential issues with the French Health authorities (ANSM) and/or Bayer competitors.
- By timely updating the legally required texts on promotional documents.
- By taking part in managing the stock of publicity material in cooperation with other department
- Ensuring timely, with high quality and properly documented, submission of:
- labeling changes based on internal procedures
- quality related changes according to the agreed timelines
- PSUR/PBRERs and DSURs
- applications for new Marketing Authorization, line extensions and new indications, or any submissions linked to Life Cycle Management activities (LCM)
- renewals in order to keep Marketing Authorizations valid in the country
- high quality translations of Product Information for Centrally approved products /MRP/DCP
- Ensuring timely implementation of approved labeling and CMC changes into the packaging materials according to SOP and the local legislation.
- Ensuring regular monitoring of the submission status with the authorities, contributing to the preparation of answers to deficiency letters and other Authority requests in cooperation with Global functions, documenting all relevant contacts in a factual manner, checking of incoming documents and initiating their correction, if needed.
- Ensuring RA support on internal projects
- Monitoring of the local legislation and competitive environment changes, promoting awareness of Regulatory requirements within the company, influencing legal landscape via local networking
- Ensuring an EU- regulatory role to support Headquarter in defined activities, e.g. driving the EU regulatory strategy, supporting key EU submissions (MA application or Life cycle management)
- Value added to the success of the company:
- Manage the activities of the Department to ensure RA compliance, safeguarding the public Health
- Support the registration of new or extended Marketing Authorizations, approval of the marketing campaign/projects and contribute to the successful product launches which meets the division business objectives
- Ensure LCM of the existing authorizations
- Contribute to the development of European regulatory strategies and to the preparation of regulatory submissions from a region/country perspective and therefore increasing their approval chances.
- Ph.D. or M.Sc. degree in life science with a Master in Regulatory affairs
- Experience in a similar regulatory function
- Ability to be flexible to manage frequent and sudden (sometimes urgent) changes.
- Fluency in English
- Good communications skills, with adequate negotiating, interpersonal and influencing skills
- Ability to drive projects
- Leadership and open minded