Regulatory Affairs Manager Job at Nectar Lifesciences, Apply Now!

Regulatory Affairs Job at Nectar Lifesciences, Apply Now!

Join Nectar Lifesciences Ltd, a global leader in Active Pharmaceutical Ingredients (APIs) and formulations, as a Regulatory Affairs Manager for global API submissions. This role offers a dynamic opportunity to work at the forefront of global regulatory strategy, contributing to international dossier submissions, regulatory compliance, and market expansion for top-tier pharmaceutical products.

• Job Position: Regulatory Affairs Manager (APIs) : Global
• Location: Dera Bassi, Punjab, India

About The Company

Nectar Lifesciences Ltd. (NLL) is a leading organization in the Indian Pharmaceutical Industry, ranked amongst the top midsized companies in India and among the top fore runners in the Bio-Pharmaceutical industry in Asia-Pacific. NLL has a strong global presence in API & Formulation business in almost 45 countries with state-of-the-art manufacturing facilities. The company prioritizes global standards of cGMP, Environment Health Safety (EHS), and has a highly skilled workforce at all levels.

Role Description

As a Regulatory Affairs Manager, you will lead global regulatory submissions for APIs and ensure alignment with international standards across various health authorities. You will be responsible for preparing and maintaining regulatory dossiers including DMF, CEP, CADIFA, JDMF, KDMF, and CDMF, and play a critical role in enabling international product registrations and renewals.

Key Responsibilities:

• Prepare, compile, review, and submit API-related dossiers including Drug Master Files (DMFs) and country-specific formats (CEP, CADIFA, KDMF, JDMF, CDMF).

• Maintain lifecycle management for submitted documents and handle queries from global regulatory bodies.

• Collaborate cross-functionally with R&D, QA/QC, manufacturing, and business teams to gather required technical data.

• Ensure ongoing compliance with international regulatory standards including ICH, EU, USFDA, ANVISA, MFDS, NMPA, etc.

• Maintain up-to-date knowledge of changing global regulatory frameworks and proactively incorporate updates in submission strategies.

• Monitor and improve internal regulatory processes and documentation systems.

• Handle audits and inspections related to API registration and compliance.

Qualifications:

• Educational Background:
  B.Sc./M.Sc. in Chemistry or equivalent life sciences discipline.

• Experience:
  3–7 years of hands-on experience in global regulatory affairs with a focus on API submissions.

• Skills Required:

  • Solid understanding of global regulatory documentation formats (DMF, CEP, CADIFA, etc.).

  • Strong attention to detail, documentation, and organizational skills.

  • Proficiency in reviewing technical documents like COAs, stability data, specifications, and analytical methods.

  • Excellent communication and coordination skills.

  • Experience working with regulatory databases and tracking tools.

Why Join Nectar Lifesciences?

• Be part of a globally recognized pharma leader in APIs and formulations.

• Work in a regulatory-intensive, innovation-driven environment.

• Collaborate with international clients and cross-functional teams.

• Competitive compensation and growth opportunities.

• Exposure to multi-country regulatory landscapes and evolving global frameworks.

APPLY ONLINE HERE

Keywords: Regulatory Affairs Manager, Nectar Lifesciences Limited, API, Job Opportunity, Dera Bassi, Punjab, Regulatory Compliance, Pharmaceutical Industry. Regulatory Affairs Job at Nectar Lifesciences, Apply Now!