Regulatory Affairs Consultant

Whizz HR is hiring a 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
6–10 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 strong background in dossier preparation and CMC authoring, we'd love to hear from you.
📩 Apply now by sending your resume to hello@whizzhr.com or apply through LinkedIn.

Work arrangement
No