Regulatory Affairs Manager

1 week ago

Bengaluru, Karnataka, India Synapmed Full time US$ 12,00,000 - US$ 30,00,000 per year

Job Title:
Regulatory Affairs Manager

Location:
Remote

Type:
Full-time

Experience:
7+

About the Role

We are seeking an experienced
Regulatory Affairs Manager
to lead and oversee regional regulatory activities across global markets. This role requires strong leadership, strategic oversight, and hands-on expertise in regulatory submissions and health authority interactions. The ideal candidate will act as the primary interface between the sponsor and regulatory teams, ensuring compliance, efficiency, and excellence in all submission processes.

Key Responsibilities

  • Serve as the
    overall project lead and primary liaison
    with the sponsor.
  • Provide strategic
    oversight of DSUR submissions
    , ensuring timely delivery and quality compliance.
  • Manage
    communication and submissions with global Health Authorities
    (MOH, MFDS, TFDA, and others).
  • Monitor and interpret regional regulatory updates
    to ensure continued compliance with evolving standards.
  • Maintain a comprehensive
    regulatory intelligence repository
    for internal and client reference.
  • Validate and confirm
    submission routes, formats, and requirements
    for each country or region.

Qualifications & Requirements

  • Bachelor's or Master's degree in
    Pharmacy, Life Sciences, or Regulatory Affairs
    .
  • 7+ years of experience
    in regulatory affairs, preferably within pharmaceuticals, biotech, or clinical research domains.
  • Proven experience handling
    global regulatory submissions
    and coordinating with multiple health authorities.
  • Strong understanding of
    ICH, FDA, EMA, and regional regulatory frameworks
    .
  • Excellent communication, documentation, and stakeholder management skills.
  • Ability to lead cross-functional teams and manage multiple projects simultaneously.

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