Regulatory Consultant CMC

hace 1 semana

estado de méxico Syneos Health A tiempo completo

Join to apply for the Regulatory Consultant CMC - Biologics role at Syneos Health Regulatory Consultant CMC - Biologics role with Syneos Health. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient needs, and we collaborate to simplify and streamline our work to deliver faster therapies and better outcomes. Overview Syneos Health is a leading fully integrated biopharmaceutical solutions organization. Our 29,000 employees across 110 countries work to accelerate customer success and change lives. Responsibilities For non-complex and complex submissions, independently fulfill regulatory activities including research of product data relative to global or regional regulatory requirements, preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for INDs, pre-approval submission packages, product registration applications, and post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to agency interactions. Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects according to timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams to develop products throughout their life cycle. Act as a subject matter expert and assist team members with day-to-day troubleshooting, presenting solutions to project-related problems. Prepare estimates for conducting regulatory services as part of proposals. Support meetings with clients to discuss proposals, project status, and business development activities. Ensure compliance with global regulatory requirements and company policies and processes. Prepare training materials and share best practices in the regulatory area, internally and externally. Participate as regulatory support in internal or external project audits and internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process-related documentation as required. Provide oversight support to team members in executing their project responsibilities and identify when line support is required to provide additional guidance. Maintain individual training records and complete designated required training. Qualifications/Requirements Previous CMC experience with Biologics is required. Veeva Vault RIM experience is required. Open to North America and LATAM; must be able to work EST hours. Note: The description includes additional benefits, salary ranges, and company information. Details may vary by location and are subject to change. The company is committed to compliance with applicable laws and equal opportunity employment practices. Additional Information Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, and proficiency for the role. For more information about Syneos Health, visit the website at #J-18808-Ljbffr

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