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We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MSD. The successful candidate will be responsible for supporting the life cycle management of our portfolio in compliance with local regulations and company policies.
Key Responsibilities- Provide regulatory administrative support and coordination for the department, including maintenance of tracking systems and databases, minor translations, and preparation of submissions and renewals.
- Contribute to other regulatory tasks as required, including quality assurance and linguistic checks of documents.
- Assist in the preparation, translation, and QRD check of Summary of Product Characteristics and Patient Package Leaflets.
- Ensure that artwork, including all package components, is developed in a timely and correct manner and according to relevant Artwork Management procedures.
- Manage License Renewal Process according to cluster schedule and monitor timelines for GENPACK.
- Participate in cluster compliance initiatives and perform regulatory assessments for new legislation.
- B.A./B.S. with strong emphasis in medical and/or biology preferred.
- 1 or 2 years of experience in similar positions.
- Fluent in English (verbal and written) with excellent communication skills.
- Excellent organizational skills and detail-oriented, problem-solving skills.
