Manager Regulatory Affairs M/F
il y a 2 semaines
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.
Within the Women’s Health division, we advocate for the right of women and individuals to choose their own health journey, and our promise is to help them access the solutions they seek. Our product range includes personal care items for contraception (both emergency and regular), feminine hygiene, and personal lubricants (for more information: Women's Health | corporate (perrigo.com)).
We are hiring a Regulatory Affairs Manager (M/F) who will play a central role in establishing and implementing regulatory strategies to support and expand our women’s health product line. In this role, you will carry out the regulatory activities required to obtain and maintain marketing authorizations (including OTC status) and to oversee promotional information control in Europe and internationally (including the U.S.), all within the applicable regulatory timelines and requirements.
Reporting to the Global Regulatory Affairs Director for Women’s Health, your responsibilities will include the following:
- Identify, obtain, and interpretively communicate applicable national laws, regulations, guidance documents, and international or consensus standards to propose the most effective regulatory strategy for approval by management.
- Provide information on applicable regulatory procedures, associated development plans, and the type of regulatory documentation required for an initial marketing authorization application (MAA) and post-approval changes (prescription status changes, pharmaceutical changes, product information and labeling revisions).
- Perform a critical regulatory review of clinical trial protocols to ensure the necessary data is collected for regulatory submissions.
- Participate in the review of data and reports to be incorporated into regulatory files, ensuring scientific rigor, accuracy, and clarity of presentation.
- Prepare, update, and coordinate the review of product information and labeling.
- Prepare administrative sections and coordinate the preparation and review of scientific and technical sections of regulatory submissions, including clinical trial authorizations, interactions with authorities, MAA dossiers, variations, periodic reports, responses to questions, etc.
- Coordinate the publication of regulatory dossiers in the required format (eCTD).
- Ensure coordination of regulatory submissions with affiliates and local partners.
- Monitor and regularly communicate the status of regulatory files/procedures.
- Maintain up-to-date regulatory documentation and information databases.
- Perform regulatory validation of packaging components in accordance with applicable regulations and procedures, for both clinical trial products and commercialized products.
- Actively participate in activities related to the implementation of clinical trials, product launches, and regulatory updates.
- Adhere to applicable internal procedures and participate in drafting, updating, and reviewing internal regulatory procedures.
With a scientific background in chemistry, biology, or pharmacy, potentially supplemented by training in regulatory affairs, you have at least 7 years of successful professional experience in regulatory affairs, especially in a global role. You possess a solid understanding of applicable national and international laws and regulations, as well as strong skills in providing precise guidance on regulatory steps and related procedures.
- Highly autonomous, you have demonstrated an ability to work effectively as part of a team with both national and international contacts.
- Proactive and solution-oriented, you are dynamic and actively engaged with the projects you handle.
- Your organizational skills, rigor, and ability to communicate effectively allow you to successfully lead projects while ensuring the buy-in of your internal clients.
- Due to the international scope of your role, you possess fluent English.
We are based in Châtillon (92), right by the Châtillon-Montrouge station (Line 13, T6). Remote work options are available within the company.
At Perrigo France, we believe that diversity of experience, ideas, and perspectives is essential to creating a dynamic, innovative workplace. We are proud to be an equal opportunity employer, celebrating differences within our teams.
We therefore encourage applications from all qualified individuals, regardless of gender identity, sexual orientation, ethnicity, religion, age, or disability. TOGETHER, we improve lives.
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