[Hiring] Manager/Senior Regulatory CMC Consultant @Syneos Health

Role Description

The Chemistry Manufacturing Controls Manager will support the execution of global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for a small molecule. 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.

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contributes to the development of global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues in the development of global regulatory CMC strategies and submissions.
• Provides regulatory 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, LATAM, Middle East, and ICH) guidelines.
• Experience in the preparation, including writing, of 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.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

• 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.
• We are continuously building the company we all want to work for and our customers want to work with.