Whizz HR is hiring a Senior Regulatory Consultant to work with a leading Pharmaceutical company in Navi Mumbai!

We're Hiring: Regulatory Consultant (Global Regulatory Affairs)

? Location: Navi mumbai

? Experience: 6–10 Years

? Employment Type: Full-Time

We are looking for an experienced Regulatory Consultant to join our growing team. If you have strong expertise in global regulatory affairs for small molecules , hands-on experience in CMC dossier preparation , and CTD/ACTD authoring , we'd love to connect with you.

Key Responsibilities

- Manage end-to-end regulatory projects, including dossier writing, submissions, approval tracking, and query resolution.
- Prepare, review, and compile regulatory dossiers in CTD/ACTD format (Modules 1–5) , with strong expertise in Module 3 (CMC) .
- Handle regulatory submissions for US, EU, UK, Australia , and emerging markets.
- Ensure submissions comply with global regulatory requirements, internal SOPs, and quality standards.
- Maintain documentation, version control, and regulatory records.
- Provide strategic regulatory guidance to internal stakeholders and clients.
- Stay current with evolving global regulatory guidelines and health authority requirements.

Required Qualifications




- 15+ years of experience in Regulatory Affairs .
- Mandatory: Hands-on experience with small molecules/generics .
- Strong expertise in CMC dossier preparation and CTD/ACTD authoring .
- In-depth knowledge of ICH CTD guidelines and global regulatory frameworks.
- Experience with regulatory submissions across FDA, EMA, MHRA, TGA , and other international markets.
- Excellent communication, documentation, and project management skills.

Preferred Qualifications
- Experience working with biologics and biosimilars .
- Exposure to regulatory consulting or managing multiple global regulatory projects.

Please Note This role is focused on core Regulatory Affairs . Candidates with experience primarily in the following areas are not a fit :

- Medical Devices
- Clinical Trials / Clinical Research
- Regulatory Publishing
- eCTD Publishing
- R&D;
- Pharmacovigilance (PV)
- QA/QC-only roles

If you're passionate about global regulatory strategy and have a solid background in dossier preparation and CMC authoring, we'd love to hear from you. ? Apply now by sending your resume to [email protected] or apply through LinkedIn.

📌 Regulatory Affairs Consultant (Mumbai)
🏢 Whizz HR
📍 Mumbai