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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
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