Sr Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Regulatory Affairs Specialist based in India.

We are seeking an experienced Regulatory Affairs Specialist to provide regulatory expertise and support clinical research activities across India and selected regional markets. In this role, you will contribute to regulatory intelligence, submission coordination, and compliance activities, ensuring alignment with local, regional, and international regulatory requirements. You will monitor evolving regulations, interpret regulatory updates, and help project teams navigate complex clinical trial requirements. Working closely with Clinical Operations, Pharmacovigilance, Drug Safety, and other cross-functional teams, you will support timely submissions and effective regulatory processes. You will also coordinate with local regulatory consultants across neighboring countries and contribute to inspection readiness and risk management. This is an opportunity to make a meaningful contribution to clinical research and patient health within a collaborative, global, and science-driven environment.

Accountabilities:

Monitor changes to Indian clinical trial regulations, CDSCO notifications, guidelines, and applicable regulatory requirements, communicating relevant updates to the India Regulatory Affairs Manager and project teams.
Coordinate with local regulatory consultants in Pakistan, Nepal, and Sri Lanka to review regulatory updates, clarify country-specific requirements, resolve regulatory queries, and ensure timely follow-up.
Support regulatory activities through the CDSCO electronic submission systems, including the SUGAM portal, and assist with clinical trial applications, import license requirements, regulatory amendments, and applicable reporting obligations.
Maintain regulatory trackers, submission logs, approval records, and essential regulatory documentation to ensure accurate tracking of submissions, commitments, and compliance timelines.
Collaborate with Clinical Operations, Pharmacovigilance (PVG)/Drug Safety, Site Activation, and other relevant departments to coordinate regulatory submissions, safety reporting, and information exchange.
Support clinical trial safety reporting activities in India, including Serious Adverse Event (SAE) reporting, by coordinating with the PVG/Drug Safety team to facilitate timely regulatory notifications, submissions, and follow-ups.
Assist with regulatory inspection and audit readiness by preparing, maintaining, organizing, and retrieving relevant regulatory documentation.
Identify potential regulatory gaps, submission delays, and compliance risks, escalating concerns proactively to the India Regulatory Affairs Manager.
Support the delivery of regulatory guidance and specialized regulatory services to internal and external stakeholders, ensuring alignment with applicable local, regional, and ICH requirements.
Contribute to effective communication and coordination between regional and global teams, ensuring regulatory activities remain aligned with project objectives and deadlines.
Demonstrate continuous learning and adaptability by staying informed about evolving regulatory frameworks, incorporating feedback, and strengthening regulatory expertise.
Manage multiple priorities effectively while maintaining accountability for assigned deliverables, timelines, and quality standards.
Requirements:
Relevant academic qualifications or professional experience in Regulatory Affairs, Clinical Research, Life Sciences, Pharmacy, Biotechnology, or a related discipline.
Practical understanding of Indian clinical trial regulations, CDSCO requirements, regulatory notifications, and applicable clinical research guidelines.
Familiarity with the CDSCO SUGAM electronic submission portal and clinical trial regulatory processes, including clinical trial applications, import licenses, regulatory amendments, and reporting obligations.
Understanding of regulatory requirements across India and the ability to coordinate with local regulatory consultants in Pakistan, Nepal, and Sri Lanka.
Knowledge of clinical trial safety reporting requirements, particularly Serious Adverse Event (SAE) reporting and applicable regulatory timelines.
Familiarity with regulatory documentation, submission tracking, approval records, and compliance monitoring.
Basic understanding of regulatory inspections and audits, including documentation preparation, maintenance, and retrieval.
Ability to identify regulatory risks, anticipate potential compliance issues, and escalate concerns appropriately.
Strong cross-functional collaboration skills, with the ability to work effectively with Clinical Operations, Pharmacovigilance, Drug Safety, Site Activation, and other internal stakeholders.
Excellent written and verbal communication skills, with the ability to interpret regulatory information and communicate updates clearly to diverse audiences.
Strong organizational and analytical skills, with excellent attention to detail and the ability to manage multiple projects and competing priorities.
Adaptability, learning agility, and a proactive approach to professional development in an evolving regulatory environment.
Ability to work independently while contributing effectively to regional and global teams across different time zones.
Flexibility to adjust working hours when necessary to support critical deliverables, important meetings, and time-sensitive regulatory requests.
Ability to work effectively under pressure while maintaining quality, accountability, and agreed timelines.
Willingness and ability to travel when required.
Benefits:
Competitive remuneration: Attractive compensation package aligned with experience and qualifications.
Annual incentive plan: Eligibility for performance-based annual incentive bonuses.
Healthcare coverage: Access to healthcare benefits and employee well-being programs.
Professional development: Opportunities to strengthen regulatory expertise and expand knowledge of international clinical research requirements.
Career growth: Exposure to global clinical research operations and opportunities to develop within a leading science-driven organization.
Global collaboration: Opportunity to work with regional and international teams and regulatory professionals.
Meaningful impact: Contribute to clinical research activities that support the development of innovative therapies and improved patient outcomes.
Work-life balance: Supportive working environment that encourages employee health and well-being.
Innovative culture: Join a forward-thinking environment built around integrity, innovation, involvement, and professional excellence.
Work arrangement: Fully remote position based in India, with standard office hours (40 hours per week).
Additional opportunities: Potential travel and exposure to international regulatory activities, depending on business requirements.