Job Description Summary
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
Job Description
Roles and Responsibilities
- Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.
- Maintain effective engagement with local health authorities and regulatory agencies across India and South Asia. In India:
- Serve as the primary regulatory liaison to CDSCO, DCGI, NPPA, and other relevant health authorities.
- Drive the preparation, submission, tracking, and approval of regulatory applications through the CDSCO SUGAM Portal, ensuring compliance with applicable requirements and timelines.
- Oversee Regulatory Affairs teams supporting distributor markets in South Asia, including governance, compliance oversight, capability development, and conducting Regulatory Affairs Distributor Qualification Audits.
- Lead regulatory interactions with health authorities to support product approvals, renewals, variations, labelling updates, safety matters, post-approval commitments, and resolution of regulatory queries and deficiency letters.
- Provide regulatory intelligence expertise through the interpretation of evolving regulatory requirements, assessment of business impact, and development of strategic recommendations for internal stakeholders.
- Partner with Global Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Affairs, Supply Chain, and Commercial teams to support compliance, product launches, and business continuity.
- Coordinate the preparation, review, and maintenance of regulatory documentation and records within Veeva Vault, TrackWise Digital, and other applicable systems.
- Represent the company during regulatory inspections, authority meetings, industry forums, and stakeholder consultations.
- Serve as a subject matter expert and mentor, leading cross-functional projects of varying complexity, influencing stakeholders, building consensus, and managing sensitive issues and competing priorities.
- Operate with a high degree of autonomy, applying sound judgment and regulatory expertise to address complex challenges, drive compliance, and ensure the consistent implementation of global procedures and best practices.
Required Qualifications
- Bachelor's degree from an accredited university or equivalent knowledge and experience.
- Minimum of 8 years of Regulatory Affairs experience within the pharmaceutical industry.
- Advanced expertise in pharmaceutical Regulatory Affairs, including regulatory strategy, product registration, lifecycle management, and compliance.
- Desired Characteristics
- Strong verbal and written communication skills, with the ability to effectively engage and influence stakeholders at all levels.
- Demonstrated analytical and problem-solving skills, with the ability to evaluate complex issues and develop practical solutions
- Ability to plan, prioritize, and execute programs and initiatives, delivering high-quality outcomes in a dynamic environment.
- Well-developed project management skills, with the ability to manage multiple priorities and drive projects to completion.
Additional Information
Relocation Assistance Provided: No
