15 Sep
|
HR Consultancy
|
Navi Mumbai
15 Sep
HR Consultancy
Navi Mumbai
Role Summary
Reporting to the Regional Regulatory Head, the Regulatory Manager, India & Middle East is responsible for defining and implementing regulatory strategies that enable compliant, timely and sustainable business growth across India and Middle East markets.
The role serves as the primary regulatory business partner and regulatory voice for the IME organization. It influences portfolio, innovation, market-entry, product-classification and launch decisions by translating complex regulatory requirements into clear business options, risk assessments and actionable recommendations.
The Regulatory Manager oversees a large and diverse product portfolio, balancing the operational demands of high-volume categories, particularly cosmetics, with the technical complexity and higher regulatory risk associated with OTC products, medical devices, dietary supplements, household products and electrical products.
This position works closely with Commercial, Marketing, R&D;, Quality, Legal, Supply Chain, Product Development and Global Regulatory Affairs to establish priorities, resolve regulatory barriers and balance compliance, business value, resource requirements and speed to market. It also leads interactions with distributors, consultants, agencies and, where appropriate, regulatory authorities.
Success in this role requires a combination of regulatory leadership, sound technical judgment, portfolio management, execution discipline, cultural awareness and the ability to influence senior stakeholders without relying on direct authority.
Strategy and Functional Expertise
- Develops and implements regulatory strategies that support compliant and sustainable business growth across India and the Middle East.
- Provides regulatory feasibility assessments for new products, market expansion, product classifications, claims and portfolio changes.
- Balances regulatory compliance, business risk and speed to market, particularly across cosmetics, OTC products, medical devices, dietary supplements, household products and electrical products.
- Translates complex regulatory requirements into clear business options and actionable recommendations.
- Applies sound regulatory judgment in ambiguous situations and identifies when technical or senior-level escalation is required.
- Monitors regulatory developments and assesses their potential impact on products, launches and business continuity.
- Maintains accurate regulatory documentation, performance metrics and management reporting.
- Promotes standardized, risk-based and efficient regulatory processes for a high-volume, multicategory portfolio.
Leadership and Influence
- Acts as the regulatory voice and trusted business partner for India and Middle East leadership.
- Influences senior stakeholders and cross-functional teams without relying on direct authority.
- Leads discussions involving regulatory risk, portfolio priorities,
market entry, product classification and speed-to-market decisions.
- Provides clear direction, removes obstacles and holds the regulatory team and stakeholders accountable for agreed deliverables.
- Develops team capability through coaching, feedback, knowledge sharing and stretch assignments.
- Builds effective relationships across Commercial, Marketing, R&D;, Quality, Legal, Supply Chain, Product Development and Global Regulatory Affairs.
- Communicates complex issues clearly and persuasively, adapting the message to technical and nontechnical audiences.
- Demonstrates openness, curiosity and a willingness to listen to different perspectives, challenge assumptions and learn from local-market expertise.
- Promotes collaboration, inclusion and trust across organizational, geographic and cultural boundaries.
Program Development / Project Management
- Leads regulatory programs and projects from strategy through implementation, ensuring clear scope, priorities, ownership and timelines.
- Manages multiple registrations, renewals, amendments, launches and regulatory-change initiatives simultaneously.
- Prioritizes projects according to regulatory risk, business impact, urgency and resource requirements.
- Monitors project progress, performance, deadlines, dependencies and spending.
- Anticipates regulatory barriers and coordinates timely actions to resolve issues.
- Works cross-functionally to identify market and distributor requirements and convert them into executable plans.
- Establishes practical governance, metrics and reporting to support timely decisions and stakeholder visibility.
- Manages consultants, agencies and other external partners, ensuring quality, confidentiality, accountability and effective use of resources.
- Identifies opportunities to simplify processes, reduce rework and improve regulatory productivity.
Impact / Reach
- Supports a diverse, high-volume portfolio across India and multiple Middle East markets.
- Influences strategic and operational decisions involving regulated products, market access, launches and business continuity.
- Operates across country, regional and global teams, connecting local regulatory requirements with broader business priorities.
- Builds strong internal and external partnerships with business leaders, distributors, consultants, agencies and regulatory authorities.
- Demonstrates agility and cultural awareness when working across different markets, regulatory systems and business practices.
- Works openly and effectively in multicultural environments, respecting local perspectives while maintaining global standards.
- Creates clarity and alignment in complex situations where regulatory, commercial, technical and supply considerations may compete.
- Adjusts communication style, content and approach to meet the needs of different cultures, functions and levels of seniority.
Education and Experience
- University degree from an accredited institution in pharmacy, chemistry, life sciences, engineering, regulatory affairs or another relevant technical field.
- Significant progressive experience in Regulatory Affairs within consumer health, consumer products or another multicategory regulated environment.
- Demonstrated experience supporting India, Middle East, GCC markets or similarly complex and diverse regulatory environments.
- Broad regulatory knowledge across at least two relevant categories, such as cosmetics, OTC medicines, medical devices, dietary supplements, household products, consumer products or electrical products.
- Experience managing high-volume portfolios and technically complex or ambiguous regulatory matters.
- Previous supervisory, people-management or team-lead experience.
- Experience working with distributors, consultants, agencies and regulatory authorities.
- Professional proficiency in written and spoken English; additional languages relevant to India and Middle East are advantageous.
- Experience working successfully with geographically dispersed and multicultural teams.
Skills and Competencies
- Strong strategic thinking, regulatory judgment and business acumen.
- Results-oriented, action-oriented and accountable for delivery.
- Ability to make timely, high-quality decisions with incomplete or changing information.
- Excellent prioritization and portfolio-management capabilities.
- Strong project and program-management skills.
- Excellent verbal, written, presentation and negotiation skills.
- Ability to explain complex regulatory matters clearly, concisely and persuasively.
- Strong influencing and stakeholder-management capabilities.
- Demonstrated ability to manage multiple projects and deadlines simultaneously.
- Open-minded, curious and willing to explore alternative regulatory pathways and solutions.
- Comfortable asking questions, seeking different perspectives and constructively challenging established approaches.
- Culturally aware, adaptable and genuinely open to working with diverse teams, markets and ways of doing business.
- Robust collaboration, relationship-building and conflict-resolution skills.
- High attention to detail, organization, accuracy and confidentiality.
- Resilient and effective in complex, ambiguous and rapidly changing environments.
- Committed to continuous learning, process improvement and practical innovation.
📌 Regulatory Manager (Navi Mumbai)
🏢 HR Consultancy
📍 Navi Mumbai