Sr Regulatory Affairs Specialist

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.

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