Regulatory Device CMC Manager
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Job Description
Device CMC Manager supporting regulatory strategies for marketed and development products. Collaborating with cross-functional teams to ensure compliance with regulatory requirements at Syneos Health.
Responsibilities:
- Reviews device sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Contributes to the development of global regulatory device strategies for commercial products
- Works with regulatory colleagues in development of global regulatory drug device CMC strategies and Submissions
- Provides regulatory drug device CMC guidance to cross-functional teams and key stakeholders
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Requirements:
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
- Experience in the preparation, including writing, of drug device CMC submissions
- Strategic thinking and strong problem solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
- Sound knowledge of cGMP, FDA, EMA, ICH
- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.
Benefits:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
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