Job Description
Note:
The job is a remote job and is open to candidates in USA. Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The Regulatory Consultant CMC - Small Molecule will conduct research on regulatory requirements, prepare submissions for regulatory agencies, and manage day-to-day regulatory activities for assigned projects. Responsibilities • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions • Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions • Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies • Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems • Prepare estimates for conducting regulatory services as part of single or multiple service proposals • Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes • Prepare training materials and share best practices in the regulatory area, both internally and externally • Participate as regulatory support in internal or external project audits • Participate as regulatory support on internal cross-functional initiatives • Contribute to the creation and/or maintenance of SOPs and other process related documentation as required • Provide support in oversight to team members in the execution of their project responsibilities • Capable of identifying when to ensure line support required to provide additional guidance and direction • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training Skills • Previous CMC with Biologics is required • Veeva Vault RIM experience is required • Open to NA and LATAM - must work EST hours Benefits • Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture Company Overview • Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
It was founded in 1985, and is headquartered in Morrisville, North Carolina, USA, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • Syneos Health has a track record of offering H1B sponsorships, with 27 in 2025, 26 in 2024, 49 in 2023, 63 in 2022, 84 in 2021, 63 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job