Job Description:

Senior Manager Regulatory Affairs (ASPAC)

Location - Mumbai-Andheri

About the company:

A leading multinational diagnostics and medical devices organization focused on innovative healthcare testing and disease detection solutions.

About the Role:

We are seeking an experienced Senior Manager Regulatory Affairs to lead regulatory strategy, product registrations, and lifecycle management activities across the Asia-Pacific region, including ASEAN countries, India, Korea, Australia, and other key markets.

The role will be responsible for ensuring compliance with applicable regulatory requirements, supporting new product introductions, maintaining existing product registrations, and partnering with cross-functional stakeholders to facilitate business growth and market access across the region.

Key Responsibilities:

- Provide regulatory guidance to commercial, quality, R&D, and operations teams to support product launches, market expansions, and lifecycle management activities.

- Develop and execute regulatory strategies for product registrations and approvals across multiple Asia-Pacific markets.

- Prepare, review, and submit regulatory documentation required for product registrations, renewals, amendments, and compliance activities.

- Assess the regulatory impact of product changes and determine applicable submission and filing requirements.

- Manage interactions with regulatory authorities, distributors, consultants, and industry associations to facilitate approvals and maintain compliance.

- Monitor evolving regulatory requirements and communicate potential business impacts, risks, and opportunities.

- Support regulatory budgeting activities, including submission costs, local testing requirements, and consultant management.

- Maintain regulatory records, databases, trackers, and documentation to ensure accuracy and compliance.

- Support trade compliance and legal distribution requirements through enterprise systems and internal processes.

- Participate in audits, inspections, and quality management system activities as a regulatory subject matter expert.

- Drive continuous improvement initiatives for regulatory processes, tools, and project management practices.

- Develop and deliver training programs related to regulatory requirements and internal procedures.

- Collaborate with regional and global stakeholders to align regulatory strategies and business objectives.

- Mentor and provide guidance to regulatory team members and support their professional development.

Required Qualifications:

- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Medical Engineering, or a related scientific discipline.

- Advanced degree (Master's or PhD) preferred.

- 12+ years of experience within the Medical Device, In Vitro Diagnostics (IVD), Biotechnology, or Pharmaceutical industry.

- Minimum 6 years of progressive Regulatory Affairs experience with increasing responsibility and leadership exposure.

- Hands-on experience managing regulatory submissions, product registrations, and lifecycle management activities across Asia-Pacific markets.

- Strong understanding of regulatory pathways and approval requirements in multiple international markets.

- Experience interacting directly with regulatory authorities, notified bodies, distributors, consultants, and industry associations.

- Demonstrated leadership, stakeholder management, and project management capabilities.

- Strong analytical, problem-solving, communication, and negotiation skills.

- Ability to manage multiple priorities, budgets, and complex regulatory projects simultaneously.

- Proficiency in Microsoft Office applications.

Preferred Qualifications:

- Advanced knowledge of medical device and IVD regulations across global and Asia-Pacific markets.

- Strong understanding of Quality Management Systems (QMS), GMP, and compliance requirements.

- Experience supporting cross-functional teams including Clinical, R&D, Product Management, Quality, and Commercial Operations.

- Proven ability to influence stakeholders and drive regulatory strategy in a matrix organization.

Key Competencies:

- Regulatory Strategy & Compliance

- Product Registration & Market Access

- Stakeholder Management

- Team Leadership & Mentoring

- Project & Budget Management

- Regulatory Intelligence

- Risk Assessment & Decision Making

- Cross-functional Collaboration

- Process Improvement & Operational Excellence

Role: Head - Regulatory Affairs

Industry Type: Medical Devices & Equipment

Department: Legal & Regulatory

Employment Type: Full Time, Permanent

Role Category: Corporate Affairs

Education:

UG: B.Sc in Any Specialization