Syneos Health

Senior Regulatory Consultant, CMC – API, EU Market

Syneos Health

full-time

Posted on:

Location Type: Hybrid

Location: Gurugram • United States

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Job Level

Senior

About the role

  • Responsible for day-to-day contribution to project teams and projects.
  • Acts as a representative of the GRAS regulatory department with other departments.
  • Contributes technical expertise to proposals and assists with Business Development initiatives.
  • Understands project budgets, scope of projects, allocated hours, and tracks compliance.
  • Interacts with internal and external personnel, clients, and technical experts on projects.
  • Conducts regulatory research on projects as needed.
  • Provides operational advice to clients.
  • Prepares consulting reports under guidance.
  • Arranges, leads, and reports on client meetings.
  • Contributes to regulatory agency meetings.
  • Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.
  • Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.
  • Acts as a resource for technical knowledge.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of the regulatory systems and infrastructure needed for GRAS.
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.
  • Provides internal training in appropriate areas of expertise to other Departments.
  • May act as a Line Manager to a small team, dependent on the location.

Requirements

  • Demonstrated experience in authoring and reviewing Module 3 CMC sections for post-approval CMC variations and other lifecycle maintenance activities, according to current global regulations and guidelines (EU mandatory +ROW market)
  • Strong experience in review and support the preparation of CMC variation applications (e.g., EU Type IA, IB, II variations; US CBE, PAS; ROW changes).
  • Experience in API Drug product (DP) related variations
  • Site Transfer related experience
  • Proven ability to work independently and proactively identify and resolve issues.
  • Strong organizational skills and ability to manage multiple priorities in a deadline-driven environment.
Benefits
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to building an inclusive culture – where you can authentically be yourself.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory researchIND authoringproduct registrationCMC variationsAPI Drug product variationspost-approval maintenanceregulatory submissionsquality improvementregulatory systems development
Soft Skills
organizational skillsproblem-solvingindependent workproactive identification of issuescommunicationleadershipteam management