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Job Opportunity in Regulatory Affairs – Pulse Pharma
Pulse Pharma, a leading pharmaceutical company with a strong focus on Biologics and Biosimilars, is hiring a Regulatory Executive to join its growing Regulatory Affairs team at Hyderabad. This role offers an excellent opportunity to work on high-impact biologic products in a fast-growing biotech environment.
🏢 About Pulse Pharma
Pulse Pharma is a dynamic and forward-thinking pharmaceutical company based in the vibrant biotech hub of Hyderabad. With 28 years of progression, the company is dedicated to developing, manufacturing, and delivering high-quality, accessible Biologics and Biosimilars. Pulse Pharma emphasizes innovation, regulatory excellence, and improving patient lives globally.
📌 Job Details
- Job Title: Regulatory Executive – Biologics & Biosimilars
- Department: Regulatory Affairs
- Industry: Pharmaceuticals (Biologics)
- Employment Type: Full Time
- Location: Hyderabad, India
🔬 Key Responsibilities
- Prepare, compile, and submit high-quality regulatory dossiers for Biologics & Biosimilars to authorities such as CDSCO, USFDA, EMA, etc.
- Manage end-to-end regulatory activities including new product applications, amendments, variations, renewals, and post-approval changes.
- Handle regulatory agency queries, deficiency letters, and official correspondence.
- Stay updated with evolving regulatory guidelines for biologics and biosimilars across key global markets.
- Review and approve product labeling, promotional materials, and change controls from a regulatory perspective.
- Collaborate closely with R&D, QA, Manufacturing, and Clinical teams to ensure lifecycle regulatory compliance.
Required Skills
✅ Must Have
- Proven experience in drafting and submitting regulatory dossiers (Module 2 & 3 experience preferred).
- Strong understanding of regulatory pathways such as IND, NDA, BLA, ANDA.
- Knowledge of guidelines from CDSCO, ICH, WHO, USFDA, EMA.
- Excellent written and verbal communication skills.
- Strong attention to detail and organizational abilities.
➕ Good to Have
- Experience in CMC documentation for biologics.
- Knowledge of post-approval regulatory maintenance.
- Ability to work in a fast-paced, result-oriented environment.
🎓 Qualifications
- Education: M.Pharm / M.Sc (Biotechnology / Life Sciences) or equivalent
- Experience: 3 to 5 years of hands-on Regulatory Affairs experience in Biologics and/or Biosimilars
What Pulse Pharma Offers
- Opportunity to work on innovative and impactful biologic products
- Supportive and collaborative work culture
- Competitive compensation and benefits package
- Career growth in a company with a clear long-term vision
📩 How to Apply
Interested candidates should send their updated resume and a cover letter explaining their suitability for the role to:
📧 talenthub@pulsepharma.net
📝 Subject Line: Application for Regulatory Executive – Biologics
🚀 Ready to Power the Future of Biologics?
If you’re passionate about regulatory affairs and want to contribute to bringing complex biologic therapies to market, apply now and be part of Pulse Pharma’s journey.
