Job Title: Assistant Manager Regulatory Affairs (Europe Market)

Location: Lower Parel, Mumbai
Industry: Pharmaceuticals / API / Excipients
Experience: 4-8 Years
Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry, Life Sciences) or equivalent

Job Summary

We are looking for an experienced Assistant Manager Regulatory Affairs (Europe Market) to manage regulatory submissions and ensure compliance for APIs and Excipients in the European market. The ideal candidate should have hands-on experience in preparing, compiling, submitting, and maintaining regulatory dossiers such as ASMFs, DMFs, and CEPs while coordinating with European regulatory authorities.

Key Responsibilities

- Prepare, compile, submit, and maintain ASMFs, DMFs, and CEPs for the European market.
- Independently prepare CTD Modules I, II, and III for API and Excipient registrations.
- Ensure regulatory compliance with EMA, EDQM, and European regulatory guidelines.
- Coordinate initial submissions, renewals, variations, and lifecycle management activities.
- Create and manage company accounts on international regulatory portals.
- Monitor changes in European regulatory requirements and provide regulatory guidance to internal teams.
- Liaise with regulatory authorities to address queries and obtain approvals.
- Prepare and maintain regulatory documentation, submission records, approvals, and correspondence.




- Support internal and external regulatory audits and inspections.
- Collaborate with R&D;, Quality Assurance, Manufacturing, and Commercial teams to ensure timely regulatory support.
- Maintain accurate regulatory databases and submission trackers.
- Provide training and guidance on regulatory compliance and documentation.

Required Skills

- Strong knowledge of European Regulatory Affairs for APIs and Excipients.
- Hands-on experience in ASMF, DMF, and CEP preparation and submission.
- Good understanding of CTD/eCTD documentation (Modules I, II & III).
- Familiarity with EMA, EDQM, and European National Competent Authorities.
- Experience with regulatory submission software such as Pharmaready and Lorenz.
- Robust knowledge of regulatory research and compliance requirements.
- Excellent documentation, communication, and analytical skills.
- Ability to manage multiple submissions and meet regulatory timelines.

Education

- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Life Sciences, or a related scientific discipline.

Experience

- 4–8 years of Regulatory Affairs experience.
- Mandatory experience in API or Excipient regulatory submissions for the European market.

Interested candidates can share their CV on this number- (phone hidden) or Mail on [email protected]

Thanks & Regards

Aakansha Adhikari

Technical Consultant

📌 Regulatory Affairs -Excipient/Active pharmaceutical Ingredient- Europe (Mumbai)
🏢 iQuest Management Consultants
📍 Mumbai