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Head of Regulatory Affairs

https://www.randstad.com Logo

Randstad

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Location:
India , Chennai

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

The Head of Regulatory Affairs is responsible for providing strategic leadership, oversight, and execution of all regulatory activities within the organization. This role ensures that the CRO maintains compliance with global regulatory standards (FDA, EMA, MHRA, CDSCO, etc.) and supports clients in achieving regulatory milestones efficiently and compliantly.

Job Responsibility:

  • Develop and implement the CROs regulatory strategy aligned with corporate goals and client needs
  • Serve as the primary regulatory expert and advisor to senior management and project teams
  • Lead and mentor the Regulatory Affairs team
  • Build and maintain relationships with global regulatory agencies and industry associations
  • Oversee preparation, review, and submission of regulatory documents including INDs, NDAs, BLAs, ANDAs, IMPDs, CTAs, and other filings
  • Ensure regulatory compliance in all clinical trials
  • Develop and maintain global regulatory intelligence
  • Support clients with regulatory strategy, gap analysis, and submission planning
  • Establish and oversee systems for document management, tracking, and reporting of regulatory submissions
  • Partner with Business Development and Project Management teams to provide regulatory input during proposal development and client meetings
  • Advise sponsors on regulatory pathways, expedited programs, and global submission strategies
  • Represent the company in regulatory meetings, audits, and inspections
  • Collaborate closely with Quality Assurance to ensure regulatory compliance
  • Monitor internal processes to ensure they align with ICH-GCP, FDA, EMA, and local regulatory requirements
  • Lead preparation and response to regulatory inspections and audits
  • Work closely with Clinical Operations, Medical Writing, Pharmacovigilance, and Data Management teams
  • Provide regulatory guidance in protocol design, informed consent, and clinical study documentation

Requirements:

  • Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field
  • Minimum of 10-15 years of experience in Regulatory Affairs
  • At least 5 years in a leadership role within a CRO or biopharmaceutical organization
  • Proven experience in global regulatory submissions and interactions with major health authorities (FDA, EMA, MHRA, CDSCO, etc.)
  • In-depth understanding of clinical development, GCP, and ICH guidelines
  • Strong track record in managing teams and leading complex regulatory projects across multiple therapeutic areas
  • Exceptional leadership, communication, and negotiation skills
  • Ability to translate complex regulatory requirements into practical strategies
  • Strong client relationship management and presentation abilities
  • High attention to detail with strong organizational and problem-solving skills

Additional Information:

Job Posted:
December 23, 2025

Expiration:
February 15, 2026

Employment Type:
Fulltime
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