Senior Regulatory Affairs Specialist

This role is for one of Weekday’s clients

Salary range: Rs 2500000 - Rs 3500000 (ie INR 25 - 35 LPA)

Min Experience: 15+ years

Location: Mumbai

JobType: full-time

We are seeking a highly experienced Senior Regulatory Affairs Specialist with 15-25 years of experience in regulatory affairs, with strong expertise in MENA markets and experience working across regulated markets. The ideal candidate will have a deep understanding of pharmaceutical, healthcare, medical device, or related regulatory frameworks and will be responsible for developing and executing regulatory strategies, managing submissions, ensuring compliance, and supporting market access across multiple geographies.

Requirements

Key Responsibilities

• Develop and execute regulatory strategies for product registrations, lifecycle management, variations, renewals, post-approval changes, and other regulatory activities across MENA markets.
• Manage end-to-end regulatory submissions and ensure that dossiers, supporting documents, labeling, packaging materials, and technical information comply with applicable country-specific requirements.
• Serve as a key regulatory point of contact with health authorities and regulatory agencies across the Middle East and North Africa region.
• Monitor regulatory developments, guidelines, legislation, and changes in registration requirements across MENA and other regulated markets and assess their potential business impact.
• Coordinate with cross-functional teams including Quality, Medical Affairs, Clinical, Pharmacovigilance, Supply Chain, Manufacturing, Legal, and Commercial teams to ensure timely regulatory deliverables.
• Review and provide regulatory guidance on product development, manufacturing changes, labeling, promotional materials, and other business initiatives.
• Lead responses to regulatory authority queries, deficiency letters, requests for additional information, and other correspondence.
• Manage product renewals, variations, license maintenance, safety updates, and other post-approval regulatory requirements.
• Establish submission plans, regulatory timelines, priorities, and risk mitigation strategies for multiple products and markets.
• Support regulatory due diligence, new product launches, business expansion, and market-entry initiatives.
• Maintain accurate regulatory documentation, submission trackers, databases, and product registration records.
• Provide strategic regulatory advice to senior leadership and internal stakeholders on market-specific requirements and potential regulatory risks.
• Mentor junior regulatory professionals and contribute to building regulatory capabilities within the organization.

Must-Have Skills

• MENA Market: Extensive hands-on regulatory affairs experience across MENA countries, with strong understanding of local registration processes and health authority expectations.
• Regulated Market: Proven experience working with highly regulated markets and complex regulatory frameworks.
• Regulatory Strategy: Strong ability to develop and implement regulatory strategies throughout the product lifecycle.
• Regulatory Submissions: Expertise in preparing, reviewing, coordinating, and maintaining regulatory dossiers and submissions.
• Health Authority Management: Experience managing regulatory interactions, meetings, queries, and negotiations with health authorities.
• Compliance: Strong knowledge of applicable regulatory guidelines, legislation, quality requirements, and post-approval obligations.
• Stakeholder Management: Ability to collaborate effectively with senior internal and external stakeholders across multiple functions and geographies.
• Problem Solving: Strong analytical skills with the ability to identify regulatory risks and develop practical solutions.

Experience & Qualifications

• 15-25 years of professional experience in Regulatory Affairs, preferably within pharmaceuticals, biotechnology, medical devices, healthcare, or a closely regulated industry.
• Extensive experience managing regulatory activities across MENA markets.
• Demonstrated experience working in regulated markets with complex product registration and compliance requirements.
• A degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Medicine, or a related discipline is preferred.
• Strong written and verbal communication skills, with the ability to work effectively in international and cross-functional environments.
• Ability to manage multiple regulatory projects, priorities, and deadlines while maintaining a high level of accuracy and compliance.