Shalina Healthcare Hiring Senior Executive – Regulatory Affairs

Senior Executive Regulatory Affairs Openings | Navi Mumbai

Apply for Senior Executive – Regulatory Affairs at Shalina Healthcare, Navi Mumbai. Qualification: M.Sc, 7–10 years’ experience.

Shalina Healthcare, a leading multinational pharmaceutical company, is inviting applications for the role of Senior Executive – Regulatory Affairs at its Navi Mumbai facility. This position is designed for experienced professionals in drug regulatory submissions, dossier preparation, and international compliance who aspire to contribute to healthcare access across African and Middle Eastern markets.

Company Overview

Shalina Healthcare has established itself as a trusted name in the pharmaceutical, nutraceutical, and healthcare sector, with a focus on delivering high-quality and affordable medicines across emerging markets. The company has a strong presence in Africa, Middle East, and Asia, and is known for its expertise in regulatory affairs, product registrations, and compliance management. Shalina combines global regulatory knowledge with local expertise to support its expansion in semi-regulated and regulated markets.

Job Role & Responsibilities

As a Senior Executive – Regulatory Affairs, you will:

• Prepare dossiers for product registration and renewal in African and Middle Eastern markets (CTD and regional formats).
• File product variations by considering changes in finished products.
• Manage local FDA and CDSCO activities as required.
• Check and approve product artworks for semi-regulated and regulated markets.
• Coordinate with manufacturing units (LL & TP) for submission documents and samples.
• Handle queries and communications with regulatory authorities.
• Maintain updated regulatory archives and databases for identified markets.
• Arrange IMC and country embassy legal documents as required.
• Support new product development projects from a regulatory perspective.
• Assist the Regulatory Head/Technical Head in additional assignments as needed.

Eligibility / Qualifications

• Educational Qualification: M.Sc in Life Sciences, Chemistry, or related disciplines.
• Experience: Minimum 7–10 years in Regulatory Affairs, with at least 5 years in African and Middle Eastern submissions.
• Skills & Expertise:
  • Strong understanding of FDA, CDSCO, ICH, and CTD guidelines.
  • Proficiency in dossier preparation, submission, and variation filing.
  • Excellent communication and coordination abilities.
  • Strong documentation and compliance management skills.

Location & Salary

• Location: Navi Mumbai, Maharashtra, India
• Salary: Competitive salary package based on qualifications and experience.

Application Process

Interested candidates who meet the eligibility requirements are encouraged to apply directly:

Apply Here

Apply before 23rd August 2025 to secure your opportunity!

Why Join Shalina Healthcare?

• Be part of a fast-growing global pharmaceutical company with strong market presence.
• Gain international exposure working on regulatory projects across Africa and the Middle East.
• Opportunity to work with cross-functional teams in manufacturing, QA, and R&D.
• Career growth and professional development in global regulatory affairs.
• Inclusive, collaborative workplace culture that values innovation and compliance.

Frequently Asked Questions (FAQs)

Q1: What qualifications are required for this role?
An M.Sc in Life Sciences, Chemistry, or related field is required.

Q2: How much experience is needed?
Candidates must have 7–10 years of Regulatory Affairs experience, including at least 5 years in African and Middle Eastern submissions.

Q3: What are the main responsibilities of this role?
Dossier preparation, product registration, variation filing, regulatory authority communication, and compliance management.

Q4: Where is this job located?
The role is based at Navi Mumbai, Maharashtra, India.

Q5: How can I apply?
Applications can be submitted via Shalina Healthcare’s official careers portal using the link provided.

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