Humano Forte is a professional talent and business solutions organization supporting pharmaceutical and healthcare companies with regulatory compliance, documentation, and global market expansion.
The organization plays a key role in helping pharma companies navigate international regulations, product registrations, and emerging market approvals, making it an ideal workplace for experienced regulatory professionals.
Regulatory Affairs Manager Job – Key Highlights
- Company: Humano Forte
- Role: Regulatory Affairs Manager
- Location: Pune, India
- Experience: 9–15 Years
- Qualification: B.Pharm / M.Pharm / Microbiology / Related Field
- Market Exposure: LATAM, APAC, Africa, CIS
- Work Type: On-site
Job Overview
This Regulatory Affairs Manager role is designed for experienced pharma professionals who can manage global regulatory submissions, compliance strategies, and dossier preparation for emerging markets.
The position offers hands-on involvement in international product registration and regulatory lifecycle management, making it a highly strategic role in pharma operations.
Key Skills Required
✔ Expertise in CTD & ACTD dossier preparation
✔ Knowledge of emerging market regulations
✔ Strong documentation & compliance skills
✔ Experience in product registration & renewals
✔ Regulatory query handling & authority coordination
✔ Leadership and team management ability
Key Responsibilities
- Develop regulatory strategies for global markets
- Prepare and submit CTD/ACTD dossiers
- Handle product registrations and renewals
- Respond to regulatory queries and deficiencies
- Track submission timelines and approvals
- Coordinate with international regulatory authorities
- Manage documentation and compliance processes
- Oversee legalization and attestation activities
- Lead and mentor junior team members
Who Can Apply
✔ Candidates with 9–15 years of regulatory affairs experience
✔ Professionals from pharmaceutical or biotech industry
✔ Candidates with strong exposure to global markets
✔ Individuals with leadership and compliance expertise
Market Exposure
This role provides direct exposure to international pharmaceutical markets:
- LATAM (Latin America)
- APAC (Asia-Pacific)
- Africa
- CIS (Commonwealth of Independent States)
Career Growth Opportunities
Working as a Regulatory Affairs Manager offers:
✨ Global regulatory exposure
✨ Leadership and strategic decision-making roles
✨ Experience with international compliance frameworks
✨ Opportunities in multinational pharma companies
✨ Long-term career growth in regulatory affairs
Why Join This Role?
- Work on global pharmaceutical submissions
- Gain exposure to multiple regulatory frameworks
- Be part of a growing compliance-driven organization
- Enhance leadership and strategic planning skills
- Contribute to global healthcare accessibility
How to Apply
📧 Send your updated resume to: Jobs@humanoforte.com
Candidates with strong regulatory experience are encouraged to apply immediately.
Important Notes
✔ No walk-in interview (email application only)
✔ Only experienced candidates are eligible
✔ Strong documentation and compliance knowledge required
FAQs
Q1. What experience is required for this role?
👉 9–15 years in pharmaceutical regulatory affairs
Q2. What markets will be handled?
👉 LATAM, APAC, Africa, and CIS regions
Q3. Is this a remote job?
👉 No, this is an on-site role in Pune
Q4. What qualifications are required?
👉 B.Pharm, M.Pharm, Microbiology, or related degree