Dear Candidates,
We have an opportunity with clinical trial development and CRO related assets and capabilities from an existing ACRO/SMO organization that is based in Chennai. We have over 10 years of experience running clinical trials as part of the global Group.
Position Overview
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. The position requires strong leadership, scientific expertise, and deep understanding of the global regulatory landscape for clinical research, drug development, and post-marketing activities.
Key Responsibilities
Strategic Leadership
- 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, ensuring continuous skill development and high performance.
- Build and maintain relationships with global regulatory agencies and industry associations.
Regulatory Operations
- 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, from study start-up through close-out.
- Develop and maintain global regulatory intelligence to anticipate and adapt to changes in regulations and guidelines.
- Support clients with regulatory strategy, gap analysis, and submission planning.
- Establish and oversee systems for document management, tracking, and reporting of regulatory submissions.
Client & Project Support
- 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.
Quality & Compliance
- Collaborate closely with Quality Assurance to ensure regulatory compliance across the CROs operations.
- 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.
Cross-Functional Collaboration
- Work closely with Clinical Operations, Medical Writing, Pharmacovigilance, and Data Management teams to ensure regulatory requirements are met at every stage.
- Provide regulatory guidance in protocol design, informed consent, and clinical study documentation.
Qualifications and Experience
Education:
- Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field.
Experience:
- Minimum of 10-15 years of experience in Regulatory Affairs, with 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.
Skills:
- 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.
Key Performance Indicators (KPIs)
- On-time and compliant regulatory submissions.
- Client satisfaction and repeat business.
- Successful regulatory inspections/audits.
- Team performance and retention.
- Continuous improvement in regulatory processes and systems.
Interested candidates can share resumes at jhelam.s@randstad.in