Manager Regulatory Affairs

Shalina Healthcare; Navi Mumbai; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Shalina Healthcare in Navi Mumbai invites an experienced Manager - Regulatory Affairs to lead end-to-end regulatory submissions across ROW markets. You will coordinate with regulatory authorities, manufacturing sites, QA, and global teams to ensure timely registrations and compliance.

You will prepare dossiers, respond to queries, review artworks, and manage multiple submissions with strict timelines. This role requires 12–15 years in Regulatory Affairs and deep knowledge of Indian and

Qualifications

• 12–15 years of experience in Pharmaceutical Regulatory Affairs.
• Strong knowledge of Indian and international/ROW registration guidelines.
• Experience in dossier preparation, product registration, regulatory queries, and regulatory licensing.
• Exposure to Africa, Asia, CIS, Middle East, LATAM, or other ROW markets.

Responsibilities

• Prepare, compile, review, and submit country-specific regulatory dossiers on timelines.
• Manage regulatory queries and requests for information from authorities.
• Review and approve product artworks, labels, and packaging for markets.
• Coordinate with manufacturing for samples and regulatory documents.
• Maintain regulatory archives, submission trackers, and records.
• Manage online applications for Product Permission, Form-29, COPP, PVSS-COPP, FSC, Wholesale Licence, WHO-GMP, Fresh Manufacturing Licence, and renewals.
• Coordinate with local FDA/regulatory authorities for submissions and clearance.
• Prepare and follow up on Form-29 NOC and Form-11 with CDSCO.
• Liaise with OU Regulatory teams and stakeholders to ensure timely submissions.
• Monitor submission timelines and drive actions to avoid delays.
• Support regulatory activities for new launches, renewals, variations, and post-approval requirements.
• Stay updated on regulatory guidelines for ROW markets.

Skills

Regulatory affairs

Coordination

Stakeholder management

Documentation

Job description

Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match and our brands are among the most trusted in Africa.

We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve.

Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.

The Global Supply Organisation is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included; Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics.

Role: Manager - Regulatory Affairs

Reporting to : Head - Regulatory

What you become a part of:

Manager Regulatory affairs will be responsible for end-to-end regulatory submission and registration activities across assigned ROW markets, ensuring timely, accurate, and compliant submissions. The role will coordinate with regulatory authorities, manufacturing sites, Quality, and international regulatory teams to facilitate product registrations, approvals, renewals, and regulatory compliance.

What to expect:

• Prepare, compile, review, and submit country-specific regulatory dossiers in accordance with applicable guidelines and agreed timelines.
• Manage regulatory queries, deficiencies, and requests for additional information from regulatory authorities and ensure timely responses.
• Review and approve product artworks, labels, and packaging materials for regulated and semi-regulated markets.
• Coordinate with manufacturing locations for preparation and dispatch of product samples and required regulatory documents.
• Maintain and update regulatory archives, submission trackers, databases, and approval records for assigned markets.
• Manage online applications and follow-up for Product Permission, Form-29, COPP, PVSS-COPP, FSC, Wholesale Licence, WHO-GMP, Fresh Manufacturing Licence, and renewals, as applicable.
• Coordinate with local FDA/regulatory authorities for submission, clarification, and timely clearance of applications.
• Prepare, submit, and follow up on Form-29 NOC and Form-11 applications with CDSCO.
• Liaise with OU Regulatory teams, Manufacturing, QA, QC, Supply Chain, and other stakeholders to ensure timely submission and registration of products.
• Monitor regulatory submission timelines, identify potential delays, and proactively drive actions for timely approvals.
• Support regulatory activities for new product launches, renewals, variations, and other post-approval requirements.
• Stay updated on regulatory guidelines and country-specific requirements relevant to assigned ROW markets.

Desired Qualifications

Experience

• 12–15 years of experience in Pharmaceutical Regulatory Affairs, depending on the level.
• Strong knowledge of Indian and international/ROW registration guidelines.
• Experience in dossier preparation, product registration, regulatory queries, artwork review, and regulatory licensing.
• Exposure to Africa, Asia, CIS, Middle East, LATAM, or other ROW markets will be preferred.
• Strong coordination, follow-up, documentation, and stakeholder management skills.
• Detail-oriented, organized, and capable of managing multiple submissions and timelines simultaneously.