[Hiring] Regulatory Device CMC Manager @Syneos Health

Role Description

The Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for the device part of the combination device. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Key Duties & 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 the 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.

Qualifications

• 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 the 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.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.