Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have 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.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   Why Syneos Health • 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

General Position Summary   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 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  Required Education Level & Experience   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 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  Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+