Mgr​/Sr Regulatory CMC Consultant - Molecule & Veeva RIM

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.
** Job Responsibilities
** Key Duties and Responsibilities  
• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.  
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies  
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions  
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects  Required Education Level & Experience  
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field  
• Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience  
• Preferred experience supporting Small Molecule programs  Required Knowledge/Skills  
• Strong interpersonal skills to exchange complex information with others and to guide others  
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines  
• 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  
• Sound knowledge of cGMP, FDA, EMA, ICHAt  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO)…