Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have Location: Remote, ON, Canada 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. technical and therapeutic area training; 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. 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. 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 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 Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines Strong sense of planning and prioritization, and the ability to work with all levels of management 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 versatile paid time off (PTO) and sick time. Syneos complies with all applicable federal, state,



and municipal paid sick time requirements.

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+ Trial patients. Further, nothing contained herein should be construed to create an employment contract. 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.

General Position

SummaryThe Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.

Syneos

Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. #

📌 Senior Regulatory Affairs Specialist Job (Ottawa)
🏢 Syneos Health
📍 Ottawa