Pulse Pharma, a leading name in the Indian pharmaceutical and biotechnology space, is expanding its Regulatory Affairs team in Hyderabad. With 28 years of progression, Pulse Pharma continues to strengthen its presence in Biologics and Biosimilars, delivering high-quality and accessible therapies worldwide.
This is an excellent opportunity for experienced Regulatory Affairs professionals who are passionate about navigating global regulatory pathways and contributing to high-impact biologic products.
🧬 About Pulse Pharma
Based in Hyderabad’s biotech hub, Pulse Pharma is a forward-thinking pharmaceutical company focused on the development, manufacturing, and commercialization of Biologics and Biosimilars. The organization is driven by innovation, quality, and regulatory excellence, enabling faster access of life-saving therapies to patients globally.
📌 Job Details
- Position: Regulatory Executive – Biologics & Biosimilars
- Location: Hyderabad, India
- Industry: Pharmaceuticals (Biologics & Biosimilars)
- Employment Type: Full Time
- Experience Required: 3–5 Years
- Qualification: M.Pharm / M.Sc (Biotechnology / Life Sciences)
🧾 Key Responsibilities
- Prepare, compile, and submit regulatory dossiers for Biologics and Biosimilars to global regulatory authorities (CDSCO, USFDA, EMA, WHO, etc.).
- Manage end-to-end regulatory activities, including new product filings, variations, renewals, amendments, and post-approval changes.
- Handle regulatory agency interactions, including responses to deficiency letters and queries.
- Stay updated with evolving regulatory guidelines for biologics and biosimilars across global markets.
- Review and approve product labeling, promotional materials, and change controls from a regulatory compliance perspective.
- Collaborate with R&D, QA, Manufacturing, and Clinical teams throughout the product lifecycle.
🎯 Required Skills & Competencies
Must Have
- Hands-on experience in regulatory dossier preparation and submissions (Module 2–5 exposure preferred).
- Strong understanding of IND, NDA, BLA, ANDA regulatory pathways.
- Knowledge of ICH, CDSCO, USFDA, EMA, WHO guidelines.
- Excellent written and verbal communication skills.
- Strong attention to detail and documentation accuracy.
Good to Have
- Experience in CMC documentation for biologics.
- Exposure to post-approval regulatory maintenance.
- Ability to work efficiently in a fast-paced, result-oriented environment.
💼 Why Join Pulse Pharma?
- Work on innovative biologics and biosimilars in a high-growth sector.
- Collaborative and learning-driven work culture.
- Competitive salary and benefits package.
- Opportunity to play a key regulatory role in a growing organization with a strong global vision.
📩 How to Apply
Interested and eligible candidates should send their updated resume and a cover letter explaining their suitability for the role.
📧 Email: talenthunt@pulsepharma.net
