Regulatory Affairs Assistant Manager

Assistant Manager - Regulatory Affairs

Company: The Moleculez

Location: Ghatkopar, Mumbai

Work Mode: Work from Office

Experience: 5 - 8 Years

Gender: Female Candidates Only

Industry: Pharmaceutical Finished Dosage Forms (FDF) / Formulations

Employment Type: Full-Time

About The Moleculez

The Moleculez, headquartered in Mumbai with representative offices in the UAE and California, USA, is a trusted and experienced manufacturer and exporter in the Active Pharmaceutical Ingredients (API) industry, with over 30 years of expertise in the pharmaceutical sector.

As part of our growth strategy, The Moleculez is expanding its business into Finished Dosage Forms (FDF) Formulations, with a strong focus on international markets including South East Asia (SEA), CIS, East & West Africa, and the MENA region.

We are looking for an experienced Regulatory Affairs professional who can support and drive regulatory activities for our expanding FDF business across international markets.

Role & responsibilities

• Manage end-to-end Regulatory Affairs activities for pharmaceutical formulations/FDF products.
• Prepare, review, compile, and maintain regulatory dossiers and submission documents.
• Handle product registrations, renewals, variations, amendments, and regulatory submissions.
• Support preparation of CTD, ACTD dossier/eCTD and country-specific dossiers.
• Coordinate with R&D, QA, QC, Production, Business Development, manufacturing partners, and overseas consultants/agents.
• Monitor regulatory requirements and guidelines for SEA, CIS, Africa, and MENA markets.
• Track submissions, approvals, regulatory queries, deficiencies, and responses.
• Prepare responses to regulatory queries and coordinate supporting documentation.
• Provide regulatory inputs for product feasibility, registration, and international market entry.
• Maintain regulatory records, trackers, and databases and ensure compliance throughout the product lifecycle.
• Support development of regulatory processes for the company's growing FDF business.

Preferred candidate profile

• Bachelor's/Master's degree in Pharmacy, Life Sciences, or related field.

• 5 - 8 years of relevant Regulatory Affairs experience, preferably in FDF/Formulations.

• Strong experience in international product registrations and regulatory submissions.

• Exposure to SEA, CIS, Africa, and/or MENA markets preferred.

• Good knowledge of dossiers, registrations, variations, renewals, and regulatory compliance.

• Strong documentation, coordination, analytical, and communication skills.

• Ability to independently manage multiple regulatory projects and meet timelines.

• Candidates from a formulation-focused pharmaceutical company will be preferred.