Pulse Pharma Hiring: Regulatory Executive (Biologics & Biosimilars)

Pulse Pharma, a dynamic leader in the Hyderabad biotech hub, is inviting applications for the position of Regulatory Executive. Specialized in the development and delivery of high-quality Biologics and Biosimilars, Pulse Pharma offers a purpose-driven environment for regulatory professionals passionate about cutting-edge innovation.

This role is pivotal in navigating the complex regulatory pathways required to bring life-changing biosimilars to global markets.

Core Responsibilities

The Regulatory Executive will manage the lifecycle of biologic products, ensuring full compliance with national and international health authorities.

Dossier Preparation: Compile and submit high-quality regulatory dossiers (focusing on Module 2 & 3) to agencies such as CDSCO, USFDA, and EMA.
Submission Management: Oversee end-to-end activities for new product applications (BLA, NDA, ANDA), amendments, renewals, and post-approval variations.
Agency Interaction: Act as a point of contact for responding to queries, deficiency letters, and technical correspondence from regulatory bodies.
Compliance Review: Review and approve product labeling, promotional materials, and change controls to ensure they meet the latest regulatory standards.
Cross-Functional Collaboration: Work closely with R&D, Quality, and Clinical teams to streamline the product journey from lab to patient.

Candidate Requirements

Pulse Pharma is looking for experts with a deep understanding of the Biologics/Biosimilar landscape.

Education: M.Pharm or M.Sc. in Biotechnology, Life Sciences, or a related field.
Experience: 3 to 5 years of hands-on experience in Regulatory Affairs, specifically within the Biologics or Biosimilars domain.
Technical Mastery: Strong knowledge of ICH, WHO, and USFDA guidelines. Experience in CMC documentation for biologics is highly preferred.
Skills: Meticulous attention to detail, strong organizational abilities, and excellent technical writing skills.

Job Summary

Location: Hyderabad, India.
Industry: Pharmaceuticals (Biologics).
Functional Area: Regulatory Affairs.
Employment Type: Full-time.

How to Apply

Interested candidates should send an updated resume and a cover letter to talenthunt@pulsepharma.net. Subject Line: “Application for Regulatory Executive – Biologies”