aurobindo Hiring Regulatory Affairs (Canada)

M.Pharm FRD → Regulatory Affairs (Canada) – Bachupally

M.Pharm (Pharmaceutics) — 1 opening for FRD-to-RA (Canada market) role in Bachupally. Apply now.

Aurobindo Pharma invites M.Pharm (Pharmaceutics) professionals with FRD experience to move into Regulatory Affairs focused on the Canada market. This role suits formulation scientists (OSD) who want to build regulatory expertise, own dossier strategy, and support global product registrations from our Bachupally facility.

Company Overview

Aurobindo Pharma is a globally recognized pharmaceutical manufacturer with a broad portfolio in generics, active pharmaceutical ingredients (APIs), and specialty formulations. Known for its compliance-first culture and robust regulatory track record, Aurobindo serves markets across North America, Europe, and emerging regions. Working here exposes you to cross-functional teams, high-volume filings, and structured career paths from R&D through regulatory operations.

Why this role matters

Regulatory Affairs is the bridge between scientific development and patient access. For a formulation researcher, transitioning into RA for the Canada market means shaping how medicines reach Canadian patients — from dossier quality to labeling compliance and post-approval lifecycle management. This role directly influences product availability, compliance with Health Canada standards, and long-term commercial success.

Job Role & Responsibilities

Primary responsibilities

• Translate FRD data into regulatory-ready documents for Canadian submissions.
• Prepare and contribute to CMC sections, quality summaries, and supporting annexes required by Health Canada.
• Assist in preparing regulatory strategies for new product entries and line extensions in Canada.
• Coordinate with manufacturing, QC, and analytical teams to compile batch records, stability data, and method validation reports.
• Support dossier assembly, review, and internal quality checks before submission.
• Respond to regulatory queries and support post-submission clarifications.
• Maintain regulatory files and product lifecycle documentation for marketed products.

Collaboration & communication

• Liaise with cross-functional stakeholders: R&D, QA, QC, production, and external regulatory partners.
• Work with global RA teams for alignment on regulatory strategy and harmonization of dossiers.
• Provide technical inputs for labeling, packaging, and artwork review when required.

Continuous improvement

• Identify gaps in dossiers and propose mitigation or data-generation plans.
• Participate in internal audits and readiness checks for Canada-specific submissions.
• Keep up to date with Health Canada guidances, regulatory updates, and Canadian pharmacopoeial changes relevant to OSD products.

Eligibility / Qualifications

• Educational qualification: M.Pharm (Pharmaceutics) preferred. B.Pharm with strong FRD background may be considered if meeting experience criteria.
• Experience: 2–3 years in Formulation Research & Development (FRD), preferably with OSD product development exposure.
• Technical skills: Hands-on understanding of formulation development, stability study design, analytical method characterization, and CMC documentation.
• Desirable: Prior exposure to dossier preparation, CMC writing, or regulatory submission processes is a plus.
• Soft skills: Clear technical writing, attention to detail, stakeholder management, and a pragmatic approach to problem-solving.

Relevant courses (comma-separated): M.Pharmacy (Pharmaceutics), B.Pharmacy, Diploma in Regulatory Affairs, Certificate in CMC Writing, Drug Regulatory Affairs courses, Postgraduate Diploma in Clinical Research, Quality Assurance Certification, Stability Study Design training.

Location & Compensation

• Work location: Bachupally (Aurobindo Pharma campus).
• Employment type: Full-time.
• Salary: Competitive and commensurate with experience (details shared during interview).
• Career path: This role offers clear progression into senior Regulatory Affairs, Global CMC roles, or regulatory project leadership.

How to Apply (quick link)

Interested candidates should email a concise CV with the subject line exactly as below:
Subject: Application – FRD- Regulatory Affairs – CA market
Email: Sreeja.Yangam@aurobindo.com

Include:

• One-page summary highlighting FRD projects and your role in formulation/stability work.
• Bullet list of technical skills (methods developed, key analytical techniques used).
• Availability and current CTC expectations.

Interview & Selection

• Shortlisting will be based on FRD experience and relevance to CMC/regulatory deliverables.
• Selected candidates will be invited for technical interviews focused on formulation problems, dossier-readiness, and Health Canada requirements.
• Expect scenario-based questions on stability failures, change controls, and how to compile a CMC section.

FAQs

Q: Is this role open to B.Pharm candidates?
A: M.Pharm (Pharmaceutics) is preferred. Strong B.Pharm candidates with 2–3 years of relevant FRD experience and demonstrable CMC exposure may be considered.

Q: How many openings are there?
A: The announcement targets a single specialist opening for the Canada market. Exact count will be confirmed during shortlisting.

Q: Will there be training on Health Canada regulations?
A: Yes. New hires receive onboarding covering Health Canada dossier expectations and internal RA processes.

Q: Can freshers apply?
A: No. This role requires 2–3 years of FRD experience.

Q: What documents should I include in my application?
A: A CV, a one-page project summary of your FRD work, and a brief skills list focusing on CMC, stability, and analytical methods.

Q: What is the interview format?
A: Initial screening by HR, technical interview with RA/R&D leads, and a final discussion with hiring manager.

Quick checklist before applying

• Update CV with specific FRD projects and data you owned.
• Prepare short bullet points on stability failures you resolved and analytical techniques used.
• Draft a concise subject line: “Application – FRD- Regulatory Affairs – CA market” and use the provided email.

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+----------------------+---------------------------------------------------------------+
| Company              | Aurobindo Pharma                                              |
+----------------------+---------------------------------------------------------------+
| Vacancies            | Regulatory Affairs (Canada market) – 1 opening                 |
+----------------------+---------------------------------------------------------------+
| Required Education   | M.Pharm (Pharmaceutics), B.Pharm (considered)                 |
+----------------------+---------------------------------------------------------------+
| Experience           | 2–3 years in Formulation Research & Development (FRD)         |
+----------------------+---------------------------------------------------------------+