Regulatory Affairs and Quality Assurance Specialist
6 days ago
The Manager, Regulatory and PV (Network) will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities. The Manager will also act as Local Contact Person for the designated country.
This role is a great opportunity to leverage your expertise in regulatory affairs and quality assurance to drive business growth and excellence. You will be responsible for ensuring compliance with department standards, developing strategy and managing setup activities, and providing expert advice to clients.
We are looking for an experienced professional who can lead global projects, manage multiple tasks, and adapt to changing work assignments. If you have a strong background in biomedical sciences, natural sciences, or health sciences, and experience within the pharmaceutical or CRO industry, we want to hear from you
Responsibilities- Assume leadership and functional representation for projects and/or deliverables of medium/high complexity, ensuring effective coordination and management of regulatory tasks.
- Develop strategy and manage setup activities (Project Management Plan, joint operating procedures, and core documents) ensuring compliance with department standards.
- Act as Local Contact Person for the designated country.
- Provide regulatory strategic input to internal and external customers and identify and address potential risks.
- Provide expert advice to clients addressing complex queries and changes in local regulations.
- University degree in Biomedical sciences, Natural sciences, or Health Sciences (Nursing, Pharmacy, or equivalent advanced degree with relevant experience).
- Strong experience within the pharmaceutical or CRO industry or regulatory body, with demonstrated experience in a leading/project management role.
- Proven ability to manage global projects.
- Excellent organizational and management skills.
- Strong planning, strategizing, and problem-solving skills.
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