
Regulatory Affairs Pharmacist
1 day ago
We're Hiring – Regulatory Affairs Pharmacist | New Delhi
Do you want to join a company that is on track to become the No. 1 Oncology & Hematology company in the Philippines next year?
If yes, this is your chance.
At GetMeds, we believe in more than just medicines. We believe in partnerships, innovation, and building a legacy of accessible, life-saving treatments. As we expand in India, we are looking for a passionate and experienced professional to join our Regulatory Affairs Team in New Delhi.
Role: Regulatory Affairs Pharmacist
Location: New Delhi, India
Salary: Up to ₹600,000 per annum
Qualifications:
Bachelor's or Master's degree in Pharmacy, Life Sciences, or related fields.
2–5 years of experience in regulatory affairs, or contract manufacturing tie-ups within the pharmaceutical industry.
Strong understanding of the Indian pharma market and licensing processes.
Excellent negotiation, communication, and relationship management skills.
Entrepreneurial mindset with the ability to thrive in a fast-paced environment.
Key Responsibilities:
Prepare, review, and submit regulatory dossiers (CTD/eCTD/ACTD) for product registration, variations, and renewals to the Food and Drug Administration (FDA/ other global authorities).
Ensure compliance with national and international regulatory requirements, guidelines, and timelines.
Maintain and update product licenses, marketing authorizations, and other regulatory approvals.
Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Marketing) to gather and verify technical documents needed for submissions.
Review product labeling, artwork, and packaging to ensure regulatory compliance.
Monitor changes in regulatory guidelines and communicate updates to management and relevant departments.
Provide regulatory support during inspections, audits, and product launches.
Keep proper records of submissions, approvals, and correspondence with health authorities.
Assist in developing regulatory strategies for new products or markets.
Support pharmacovigilance and post-marketing surveillance requirements as needed.
Skills and Knowledge:
Strong understanding of global regulatory requirements (USFDA, EMA, MHRA, TGA, Health Canada, CDSCO – India, ASEAN, WHO).
Experience in preparation, review, and submission of regulatory dossiers (DMF, ANDA, NDA, MAA, CTD/eCTD).
Knowledge of variations, renewals, post-approval changes.
Familiarity with ICH, GxP, and pharmacovigilance regulations.
Good communication and scientific writing skills.
Proficiency in MS Office, regulatory submission tools/software.
Other Requirements:
• Attention to detail and accuracy in documentation.
• Strong organizational and project management skills.
• Ability to coordinate with R&D, QA, QC, and manufacturing teams.
Why Join Us?
Be part of a company transforming cancer care access across Asia.
Work on strategic partnerships that will shape the future of oncology and hematology medicines.
Join a global team driven by purpose, growth, and impact.
Opportunity to grow alongside a rapidly expanding international pharma company.
How to Apply:
Send your CV to:
Let's build the future of healthcare together.
Hiring #PharmaJobs #Regulatory #Oncology #Hematology #GetMeds-
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