Regulatory Affairs Specialist
il y a 3 semaines
POSITION OVERVIEW
Are you ready to embark on a rewarding career with Norgine?
At Norgine, we encourage our team members to embrace innovation, strive for excellence, and foster personal and professional growth.
We believe in a holistic career experience that empowers you to bring your unique strengths to the table, whether it’s your commitment to improving healthcare, your dedication to teamwork, or your eagerness to learn in a dynamic setting.
In return, we offer a supportive environment, opportunities for continuous development, and a company culture that prioritizes employee well-being.
At Norgine, we are dedicated to enhancing lives through pioneering healthcare solutions.
We are currently seeking a Regulatory Affairs Executive to become a vital part of our team. This role will report directly to the Regulatory Affairs Manager for France and will be integrated within the Global Regulatory Affairs division.
KEY RESPONSIBILITIES
- Assist in the launch of products, new formulations, and integrations across designated countries.
- Oversee regulatory submissions and approvals, including artwork for France, Belgium, Luxembourg, and the Netherlands.
- Facilitate communication with regulatory bodies to expedite submission approvals, both independently and under the guidance of the line manager.
- Address straightforward regulatory challenges and assist in resolving more complex issues with supervision.
- Participate in project teams as needed.
- Gather and provide information for inclusion in regulatory databases (e.g., Vidal, CIP).
- Track expenditures against the budget for inclusion in financial reports.
- Maintain organized paper and electronic filing systems for assigned products/countries, adhering to Records Retention policies.
- Support compliance with local laws and codes regarding promotional activities within France.
- Assist in local MAPA activities, including the review and submission of pricing and reimbursement dossiers.
- Contribute to regulatory intelligence initiatives.
- Support the Pharmacien Responsable in overseeing activities specific to France (e.g., sales responsibility certification charter, training for operators).
- Engage with industry trade associations and external consultants as necessary.
QUALIFICATIONS
- Prior experience in regulatory affairs or the pharmaceutical sector, with a solid understanding of global regulatory standards (including GMP, GLP, and GCP) is advantageous.
- This role is ideal for candidates with up to 2 years of relevant experience.
- A comprehensive understanding of the drug development process is essential.
- Familiarity with ICH guidelines pertinent to technical responsibilities, particularly in developing a Target Product Profile and delivering a product at the conclusion of the development cycle.
- Strong analytical skills and a customer-focused approach.
- Excellent interpersonal and communication skills, both verbal and written.
- A collaborative mindset and the ability to work effectively within a team.
- Proficiency in English communication is required.
- Pharmacists eligible for registration with the Chamber of Pharmacists in France, holding an RA master or equivalent, are encouraged to apply.
COMPANY BENEFITS
Benefits may vary by location.
Interested in learning more about the opportunities available at Norgine? Explore the potential for a fulfilling career with us.
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