Hetero Hireing RA Executive/Sr Executive

B.Pharm/M.Pharm RA Executive — Hetero Jadcherla

B.Pharm/M.Pharm — RA Executive/Sr Executive (Biologics) for international regulatory submissions. Multiple vacancies at Hetero Biopharma, Jadcherla.

Hetero Biopharma is hiring experienced Regulatory Affairs professionals with a mandatory biologics background to support international regulatory submissions and lifecycle management. These Executive and Senior Executive roles at the Jadcherla site suit candidates who have hands‑on experience preparing dossiers for regulated markets, managing compliance for biologics, and coordinating cross‑functional inputs to meet global timelines.

Company Overview

Hetero Biopharma Ltd is a leading integrated biopharmaceutical company focused on biologics, biosimilars and complex generics. With a strong manufacturing footprint and global regulatory experience, Hetero serves markets across Europe, North America, Asia and other regulated territories. The Jadcherla facility is part of Hetero’s biologics and sterile manufacturing network and adheres to international standards for quality, data integrity and regulatory compliance.

Why Hetero Biopharma?

• Established track record in biologics and biosimilars development and manufacturing.
• Global regulatory exposure including dossier submissions and inspections.
• Cross‑functional teams (CMC, Clinical, QA) that enable robust regulatory strategies.
• Strong emphasis on career growth for regulatory professionals through exposure to international submissions and lifecycle management.

Job Role & Responsibilities

Position: Regulatory Affairs — Executive / Senior Executive (Biologics)

Core objective: Lead and support international regulatory submissions for biologics, ensuring dossiers meet agency expectations and are submitted on time.

Key responsibilities:

• Prepare, compile and review regulatory dossiers (CTD/eCTD) for biologics intended for international markets.
• Coordinate cross‑functional inputs from CMC, quality, clinical and pharmacovigilance to ensure completeness and accuracy of submissions.
• Manage regulatory timelines, track submission milestones and follow up on agency queries.
• Implement and maintain regulatory compliance for biologics, including adherence to ICH guidelines and region‑specific requirements.
• Support post‑submission activities: answering queries, preparing briefing documents and coordinating inspections where required.
• Maintain regulatory intelligence on evolving requirements for biologics, biosimilars and related CMC expectations in target markets.
• Draft regulatory strategies for dossier lifecycle activities including variations, renewals and post‑approval changes.
• Contribute to the creation and maintenance of SOPs and regulatory working documents.

What success looks like:

• Clean, complete dossiers delivered on schedule with minimal deficiencies.
• Effective cross‑team coordination leading to timely query resolution.
• Demonstrated understanding of biologics CMC expectations and quality attributes.

Eligibility / Qualifications

Minimum qualifications:

• B.Pharm / M.Pharm or equivalent degree in pharmaceutical sciences, biotechnology, or life sciences.

Mandatory background:

• Experience with biologics (biologics development, biologics CMC dossiers, biosimilars) is required.
• Hands‑on experience with international regulatory submissions (CTD/eCTD) for regulated markets.

Experience levels:

• Executive: Typically 2–5 years of RA exposure with at least some biologics work.
• Senior Executive: 5+ years of regulatory affairs experience with strong track record in biologics submissions and lifecycle management.

Technical skills & competencies:

• Strong knowledge of regulatory frameworks (ICH, EMA, US FDA expectations) and region‑specific dossier requirements.
• Familiarity with eCTD compilation and submission processes.
• Good understanding of biologics analytical comparability, critical quality attributes (CQAs) and stability requirements.
• Excellent written communication and document review skills.
• Ability to manage timelines, prioritize tasks and work across functional teams.

Relevant courses (comma‑separated): B.Pharm, M.Pharm, MSc Biotechnology, PG Diploma in Regulatory Affairs, Certification in Biologics & Biosimilars, eCTD submission training, Certificate in CMC Regulatory Strategy

Location & Salary

Location: Hetero Biopharma Ltd., Jadcherla, Telangana.

Salary: Competitive and commensurate with experience. Candidates with demonstrable biologics dossier experience and prior international submissions may command premium compensation.

Application Process

Interested candidates should send their CV to: maniteja.s@hetero.com

Application tips:

• Use a clear subject line such as: “Application — RA Executive (Biologics) — [Your Name]”.
• In the email body, summarise your biologics dossier experience in 3–4 lines (mention any CTD/eCTD submissions, markets covered and CMC responsibilities).
• Attach an updated CV and any relevant certificates (regulatory affairs, biologics training).

Only candidates with international regulatory submissions and biologics compliance experience will be considered.

FAQs

Q: Is biologics experience mandatory?
Yes. Candidates must have a biologics background and prior involvement in biologics CMC or dossier activities.

Q: What markets are relevant?
Experience in regulated markets (EU/EMA, USFDA, UK MHRA, Australia, Canada, or similar) is highly valued.

Q: Do I need eCTD experience?
Familiarity with eCTD compilation and submission is preferred; practical experience strengthens your application.

Q: Can remote candidates apply?
Preference is for candidates willing to work onsite at Jadcherla due to close coordination with CMC and manufacturing teams.

Q: What supporting documents should I include?
Updated CV, a brief summary of dossier work (1–2 lines per submission), and any RA or biologics related certificates.

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+----------------------+-------------------------------------------------------------+
| Company              | Hetero Biopharma Ltd                                         |
+----------------------+-------------------------------------------------------------+
| Vacancies            | Regulatory Affairs — Executive / Senior Executive (Biologics) |
+----------------------+-------------------------------------------------------------+
| Required Education   | B.Pharm, M.Pharm, MSc Biotechnology                           |
+----------------------+-------------------------------------------------------------+
| Experience           | Executive: 2–5 yrs; Senior Executive: 5+ yrs (Biologics RA)    |
+----------------------+-------------------------------------------------------------+