Hetero Hiring Regulatory Affairs Specialist
- Company Overview
- Job Role & Responsibilities
- Regulatory Affairs Specialist (Formulation — ROW, EU, US)
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why this role matters (EEAT Alignment)
- High-Value Keywords Included Naturally
- FAQs
M.Pharm/B.Pharm Regulatory Affairs Specialist — Hyderabad
M.Pharm/B.Pharm: Regulatory Affairs Specialist at Hetero, Jeedimetla. 3–9 years experience in CMC and dossier submissions.
Hetero is hiring a Regulatory Affairs Specialist for its formulation markets (ROW, EU, US) based at the Jeedimetla site in Hyderabad. This role is tailored for candidates with solid dossier preparation experience, CMC knowledge, and hands-on exposure to lifecycle management and post-/pre-approval activities. If you’ve worked on global submissions and understand regulatory expectations across multiple jurisdictions, this position offers direct involvement in international market registrations.
Company Overview
Hetero is a large, diversified pharmaceutical company with global footprints across APIs and finished formulations. The company supplies products to regulated markets and invests in regulatory capability to support approvals in EU and US regions. Hetero’s regulatory teams collaborate closely with R&D, QA, CMC, and global commercial teams to ensure dossiers meet technical and regulatory expectations.
Job Role & Responsibilities
Regulatory Affairs Specialist (Formulation — ROW, EU, US)
- Prepare, review, and compile regulatory dossiers for product registrations (CTD/eCTD and regional formats).
- Manage lifecycle activities including variations, renewals, and post-approval commitments.
- Coordinate pre-approval and post-approval submissions, responses to deficiency letters, and regulatory queries.
- Work closely with CMC teams to ensure quality sections, stability data, and manufacturing information are submission-ready.
- Support Marketing Authorization Applications (MAA) and country-specific authorization workflows.
- Maintain regulatory trackers, submission logs, and ensure timelines are met for international filings.
- Monitor regulatory changes in target markets and implement necessary dossier updates.
- Liaise with external regulatory consultants and global affiliates as required.
Eligibility / Qualifications
- Qualification: M.Pharm, B.Pharm, or M.Sc in related life-science fields.
- Experience: 3–9 years in regulatory affairs with hands-on dossier preparation and CMC exposure.
- Technical skills: Knowledge of CTD/eCTD, dossier compilation, stability data interpretation, and familiarity with MAA processes.
- Soft skills: Strong written communication, cross-functional coordination, deadline management, and attention to regulatory detail.
Relevant courses (comma-separated): M.Pharm Regulatory Affairs, B.Pharm, M.Sc Pharmaceutical Sciences, PG Diploma in Regulatory Affairs, Diploma in Quality Assurance
Location & Salary
- Work Location: Jeedimetla, Hyderabad.
- Salary: Not specified; competitive and based on experience.
- Work model: On-site at the Jeedimetla office (may involve coordination with global teams across time zones).
Application Process
Interested candidates should email their CV to: chandrasekhar.r@hetero.com
Email subject suggestion: Application for RA — [Your Name]
Include a brief summary of your dossier experience, markets handled (EU/US/ROW), and specific CMC contributions.
Why this role matters (EEAT Alignment)
Regulatory Affairs ensures that safe, effective medicines reach patients worldwide by interfacing scientific data with regulatory requirements. A specialist who can prepare robust CMC sections and manage lifecycle changes helps secure approvals, maintain market supply, and reduce regulatory risk — strengthening the company’s credibility and trust with regulators and healthcare providers.
High-Value Keywords Included Naturally
regulatory affairs jobs, CTD dossier preparation, eCTD submissions, CMC regulatory specialist, MAA submissions, pharmaceutical regulatory careers, lifecycle management in pharma.
FAQs
Q: What experience is required?
A: 3–9 years in regulatory affairs, with direct dossier preparation and CMC exposure.
Q: Which markets will I work on?
A: Primarily ROW, EU, and US markets.
Q: Is M.Sc acceptable?
A: Yes. M.Pharm, B.Pharm, and M.Sc candidates with relevant experience are eligible.
Q: Is remote work allowed?
A: The role is based in Jeedimetla, Hyderabad; occasional coordination across time zones is expected.
| Category | Details |
|---|---|
| Company | Hetero Labs Limited |
| Vacancies | Regulatory Affairs Specialist — Formulation (ROW/EU/US) |
| Required Education | M.Pharm, B.Pharm, M.Sc, PG Diploma in Regulatory Affairs |
| Experience | 3–9 years |
To apply for this job email your details to chandrasekhar.r@hetero.com
