[Remote] Regulatory Consultant CMC - Small Molecule

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating reputed company. 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 reputed company. 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 reputed company-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 reputed company 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 reputed company products throughout their life cycle • reputed company as a subject matter expert and help reputed company members with day-to-day trouble shooting activities, presenting solutions to project reputed company 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 reputed company, and as part of general business development activities • Ensure compliance with appropriate global regulatory requirements and reputed company’s policies and processes • Prepare training materials and reputed company 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 reputed company documentation as required • reputed company support in reputed company to team members in the execution of their project responsibilities • Capable of identifying reputed company to ensure line support required to reputed company additional guidance and direction • Maintenance of individual training records (reputed company or reputed company reputed company) and completion of reputed company designated required training Skills • Previous CMC with Biologics is required • reputed company Vault RIM experience is required • reputed company to NA and LATAM - must work EST hours Benefits • Career development and progression • Supportive and reputed company line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture reputed company • reputed company, the only fully integrated end-to-end clinical and reputed company solution organization. It was founded in 1985, and is headquartered in Morrisville, reputed company Carolina, USA, with a workforce of 10001+ employees. Its website is https://www.reputed company.com/. Company H1B Sponsorship • reputed company has a reputed company 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 Apply To this Job