Syneos Health

Regulatory Consultant CMC

Syneos Health

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $56,400 - $95,900 per year

Job Level

Mid-LevelSenior

About the role

  • 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, 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-to-day regulatory activities for assigned project according to agreed timelines, scope, 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.
  • 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) and sick time.

Requirements

  • 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.
  • Prepare administrative and technical components of regulatory agency submissions for the IND, pre-approval submission packages, product registration applications, and 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.