Sr Regulatory Affairs Specialist

India·Bangaloresenior

Legal & ComplianceRegulatory Affairs Specialist

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Quick Summary

Key Responsibilities

Develop and execute regulatory strategies to support expansion across JPAC markets. Lead regulatory readiness for tenders, ensuring alignment with local compliance

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Legal & ComplianceRegulatory Affairs Specialist

Responsibilities

~2 min read

→Develop and execute regulatory strategies to support expansion across JPAC markets.
→Lead regulatory readiness for tenders, ensuring alignment with local compliance requirements.
→Support setup of legal entities, distributors, or economic operator structures in new markets.
→Interpret evolving regulatory requirements and translate them into actionable strategies for business teams.
→Collaborate closely with Sales and Commercial teams to support participation in regional tenders.
→Prepare and review regulatory documentation required for tender submissions (e.g., certificates, compliance statements, regulatory approvals).
→Develop regulatory memos, justifications, and gap assessments to demonstrate compliance where formal documentation may not exist.
→Ensure timely delivery of compliant documentation aligned with tender timelines.
→Manage and support submissions to health authorities across JPAC (e.g., CDSCO, PMDA, TGA, HSA, NMPA, etc.).
→Interface with government agencies and notified bodies for approvals and registrations.
→Support company registration and licensing as a distributor, importer, or economic operator in various jurisdictions.
→Maintain regulatory intelligence on regional authority expectations and processes.
→Work cross-functionally with Quality, Clinical, Supply Chain, and Commercial teams to support regulatory and quality initiatives.
→Participate in and lead regulatory workstreams within broader business or transformation projects.
→Ensure alignment between regulatory deliverables and business objectives.
→Track and manage deliverables using project management best practices.
→Support regulatory aspects of product lifecycle management, including renewals, variations, and market expansions.
→Review and assess regulatory impact of product, labeling, or design changes.
→Coordinate submission of regulatory updates and change notifications to applicable markets.
→Ensure global regulatory documentation is adaptable to local requirements.
→Review labeling and promotional claims to ensure compliance with local regulatory requirements.
→Provide regulatory guidance on permissible claims to support commercial strategies.
→Partner with internal stakeholders to update labeling and IFUs as needed.
→Ensure consistency and compliance of regulatory documentation across markets.
→Provide insights to help shape future tender strategies and maintain competitive positioning.
→Support proactive planning by anticipating regulatory trends and risks.
→Utilize regulatory and quality IT systems (e.g., eQMS, RIM systems) to maintain accurate and compliant records.
→Drive process improvements to enhance efficiency of regulatory operations.

Requirements

~1 min read

A minimum of 2 years of work experience in a medical device Class II/ III environment.
Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
Advanced degree preferred
3-5+ years of regulatory affairs experience within the medical device or healthcare industry
Strong experience supporting JPAC regulatory environments
Proven experience with:
- Regulatory submissions and approvals across multiple APAC countries
- Government agency interactions and company registration processes
Experience in setting up distributors, legal entities, or economic operator structures is highly preferred
Strong understanding of JPAC regulatory frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)
Expertise in regulatory documentation, submissions, and compliance requirements
Proficiency in regulatory and quality IT systems (e.g., RIM, eQMS)
Strong cross-functional collaboration and stakeholder management skills
Ability to work in fast-paced, ambiguous environments with agility
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Ability to influence without authority and drive alignment across teams
High attention to detail and commitment to compliance