Fixed-term / Full Time position
Responsible and accountable for regulatory matters and act as main local regulatory contact
- Obtain new drug approvals through preparation of the required documentation and thorough follow-up with local health authorities.
- Monitor and follow up the regulatory application submission status, including variations and renewals.
- Manage regulatory inspection (as applicable) and Product life cycle maintenance of all currently registered product licenses and maintain validity of all regulatory certifications according to local regulation.
- Monitor local regulatory surveillance and perform impact assessment.
- Ensure regulatory compliance and proactively identify regulatory trends, manage new implementation and communicate potential impacts on company business according to local regulation and requirement.
- Adhere strictly the timelines in global procedure for submitting and verifying registration information/data in global regulatory database.
- Interact with the local Health Authority on an as-needed basis.
Support business operations
- Review promotional and non-promotional materials according to local regulation and global procedures.
- Provide guidance to ensure product samples are managed properly according to GDP requirement, as applicable.
- Support the preparation of technical documentation / dossier for hospital enlisting, tender application, pricing submission, custom clearance, as applicable.
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What We Do
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries. Community guidelines available here: https://re.ferring.com/Ferring-LinkedIn-Community-Guidelines Social Media Privacy Notice available here: https://www.ferring.com/social-media-privacy-notice/
