Pulse Pharma, we don't just follow the rhythm of the pharmaceutical industry - we set the beat. Based in the vibrant biotech hub of Hyderabad, we are a dynamic and forward-thinking company dedicated to developing, manufacturing, and delivering high-quality, accessible Biologies and Biosimilars. Our mission is to empower healthier lives worldwide through cutting-edge science, unwavering quality, and a passionate team that thrives on innovation. Join us, and be part of a company where your work pulses with purpose and impact.
Post : Regulatory Executive - Biologies & Biosimilars
The Opportunity
Seeking a motivated and detail-oriented Regulatory Executive to join our growing Regulatory Affairs team. This is a pivotal role where you will be instrumental in navigating the complex regulatory landscape for our biologic and biosimilar portfolio. You will work closely with cross-functional teams to ensure our products meet all national and international regulations, accelerating their journey to patients who need them.
Key Responsibilities
• Prepare, compile, and submit high-quality regulatory dossiers for Biologies & Biosimilars to regulatory authorities (CDSCO, FDA, EMA, etc.).
• Manage end-to-end regulatory activities for new product applications, amendments, variations, renewals, and post-approval changes.
• Interact with regulatory agencies for query responses, deficiency letters, and other correspondence.
• Stay updated on evolving regulatory guidelines and requirements for biologics/biosimilars in key markets.
• Review and approve product labeling, promotional materials, and change controls from a regulatory perspective.
• Collaborate effectively with R&D, Quality Assurance, Manufacturing, and Clinical teams to ensure regulatory compliance throughout the product lifecycle.
Required Skills Must Have :
• Proven experience in drafting and submitting regulatory dossiers (Module 2 & 3 expertise is a plus).
• Strong knowledge of regulatory pathways (INO, NDA, BLA, ANDA) and guidelines from CDSCO, ICH, WHO, USFDA, or EMA.
• Excellent written and verbal communication skills.
• Meticulous attention to detail and strong organizational abilities.
Good to Have :
• Experience in CMC documentation for biologies.
• Understanding of post-approval regulatory maintenance.
• Ability to work in a fast-paced, result-oriented environment.
Additional Information
Education : M.Pharm / M.Sc. (Biotechnology/ Life Sciences) or equivalent.
Experience : 3 to 5 years of hands-on regulatory affairs experience, specifically in the Biologies and/or Biosimilars domain.
Location : Hyderabad, India
Industry : Pharmaceuticals (Biologies)
Employment Type : Full Time
Send your updated resume and a cover letter explaining why you are the perfect fit for Pulse Pharma to talenthunt@pulsepharma.net with the subject line: "Application for Regulatory Executive - Biologies."
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