Regulatory Affairs Specialist

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: - ( - )

Experience: 15+ yrs

Location: Mumbai, Maharashtra, India

Job Type: Full-time

We are looking for a highly experienced Regulatory Affairs Specialist to lead and manage regulatory activities across the MENA (Middle East and North Africa) market. The role requires deep expertise in regional regulatory frameworks, product registrations, submissions, compliance, lifecycle management, and engagement with health authorities across multiple MENA markets.

The ideal candidate will bring extensive regulatory experience and a strong understanding of country-specific requirements, submission strategies, regulatory pathways, and market-entry considerations. You will play a key role in developing regulatory strategies that support successful product registration, approvals, launches, and continued market compliance.

Requirements

Key Responsibilities

• Develop and execute regulatory strategies for MENA markets in alignment with business and product objectives.
• Manage regulatory submissions, registrations, approvals, renewals, variations, and lifecycle activities across relevant MENA countries.
• Assess country-specific regulatory requirements and determine appropriate submission pathways and documentation requirements.
• Prepare, compile, review, and coordinate regulatory dossiers and submission packages.
• Ensure regulatory submissions are accurate, complete, compliant, and submitted within agreed timelines.
• Coordinate with regulatory authorities, local agents, distributors, consultants, and business partners across MENA markets.
• Respond to regulatory authority queries, deficiency letters, clarification requests, and follow-up questions.
• Monitor regulatory submissions and proactively manage timelines, dependencies, risks, and approval milestones.
• Support product launches by ensuring all applicable regulatory approvals, registrations, certificates, and documentation are in place.
• Manage post-approval activities including renewals, variations, regulatory updates, product changes, and lifecycle maintenance.
• Review and coordinate regulatory requirements related to product labelling, packaging, artwork, claims, and promotional materials.
• Maintain accurate regulatory databases, submission trackers, registration records, and compliance documentation.
• Monitor changes in MENA regulatory frameworks and assess their potential impact on products and business operations.
• Provide regulatory intelligence and guidance to internal stakeholders on evolving market requirements.
• Collaborate with Quality, Medical, Clinical, Supply Chain, Commercial, Legal, and Product teams on regulatory matters.
• Identify regulatory risks and develop appropriate mitigation strategies.
• Support audits, inspections, regulatory assessments, and compliance initiatives as required.
• Establish standardised regulatory processes and contribute to continuous improvement of regional regulatory operations.

What Makes You a Great Fit

• 15+ years of experience in Regulatory Affairs, with substantial experience managing regulatory activities across international markets.
• Strong and demonstrated expertise in the MENA market, including experience across multiple Middle Eastern and North African countries.
• Deep understanding of MENA regulatory frameworks, registration pathways, submission requirements, and post-approval processes.
• Proven experience managing end-to-end product registrations, regulatory submissions, approvals, renewals, and variations.
• Strong ability to develop regional regulatory strategies while adapting requirements to individual country regulations.
• Extensive experience coordinating with health authorities, local agents, distributors, consultants, and external regulatory partners.
• Strong regulatory documentation, dossier preparation, submission, and review capabilities.
• Excellent regulatory intelligence and ability to monitor and interpret changes in regional requirements.
• Strong understanding of product lifecycle management and post-approval regulatory compliance.
• Excellent project-management skills with the ability to manage multiple countries, products, submissions, and timelines simultaneously.
• Strong analytical, problem-solving, and risk-assessment capabilities.
• Excellent communication, negotiation, and stakeholder-management skills.
• Ability to work effectively with cross-functional and geographically distributed teams.
• High attention to detail, strong regulatory judgement, and a proactive approach to compliance.
• Ability to operate independently and take ownership of complex regional regulatory programs.