Aurobindo Hiring Regulatory Affairs

M.Pharm Regulatory Affairs – Aurobindo | Bachupally

M.Pharm (Pharmaceutics) – 1 vacancy – Regulatory Affairs (Canada Market) at Aurobindo, Bachupally. 3–5 yrs exp. Apply now.

Aurobindo Pharma invites passionate formulation scientists and regulatory specialists to apply for a pivotal Regulatory Affairs role focused on the Canada market (Quality / CMC Module). This position is designed for professionals who enjoy working at the intersection of formulation R&D and regulatory strategy — converting laboratory data into robust, market‑ready dossiers that help bring safe and effective medicines to patients in Canada. If you hold an M.Pharm in Pharmaceutics (preferred) or have strong formulation and CMC experience, and you are ready to step into a role that combines scientific depth with regulatory responsibility, read on.

Company Overview

Aurobindo Pharma is a global pharmaceutical leader with a diversified product portfolio spanning active pharmaceutical ingredients (APIs) and finished dosage forms across multiple therapeutic segments. With decades of experience, advanced manufacturing facilities, and a presence in regulated markets including the US, EU and Canada, Aurobindo is recognized for its commitment to quality, regulatory compliance and scientific rigour.

What sets Aurobindo apart is its investment in R&D and analytical capabilities — laboratories and teams that generate the formulation, stability and validation data required to support high‑quality regulatory submissions. At Aurobindo you’ll find collaborative teams comprising formulation scientists, analytical chemists, QA/QC specialists and regulatory professionals working together to ensure product quality, patient safety and timely market access.

Job Role & Responsibilities

Position: Regulatory Affairs – Canada Market (Quality / CMC Module)

Location: Bachupally, Telangana (On‑site)

Experience Required: 3–5 years

Preferred Qualification: M.Pharm (Pharmaceutics)

This role is the technical owner of the Quality (CMC) Module for products intended for the Canada market. You will be responsible for compiling, drafting and defending the CMC component of CTD/eCTD dossiers, translating formulation and analytical data into clear regulatory narratives, and responding to Health Canada queries.

Key responsibilities:

• Prepare, compile and review Quality (CMC) sections of CTD/eCTD dossiers for initial submissions, variations, and post‑approval updates targeted to Health Canada.
• Translate formulation R&D outputs — development batch reports, manufacturing process descriptions, analytical method validations, and stability studies — into scientifically justified, submission‑ready documentation.
• Draft and critically assess CMC documents: drug substance and drug product descriptions, manufacturing process controls, specifications, analytical method summaries, method validation reports and stability protocols/reports.
• Coordinate data collection and technical inputs from Formulation R&D, QC, QA and Manufacturing to ensure dossier completeness and accuracy.
• Interpret stability data, set shelf life recommendations, and provide scientific justification for specification limits and control strategies.
• Respond to Health Canada deficiency letters and technical queries with timely, science‑based replies prepared in collaboration with cross‑functional teams.
• Support lifecycle management activities including change controls, post‑approval variations and annual updates, ensuring continuous compliance.
• Track Health Canada guidance, ICH updates and pharmacopeial revisions relevant to CMC, and implement updates to templates and SOPs.
• Mentor junior writers and contribute to process improvements for dossier compilation and quality control of submission packages.

What success looks like:

A successful candidate will consistently deliver complete, defensible CMC modules that withstand regulator scrutiny, reduce review cycles, and accelerate approvals. You will demonstrate technical leadership in translating R&D data into regulatory strategy — resulting in fewer queries, faster approvals, and improved lifecycle management for marketed products.

Eligibility / Qualifications

Must‑have:

• M.Pharm (Pharmaceutics) preferred (strongly preferred).
• 3–5 years of experience in formulation R&D, CMC documentation or regulatory affairs related to Quality/CMC.

Desirable / Considered:

• B.Pharm candidates with considerable hands‑on formulation, stability and dossier experience may be evaluated.
• Prior exposure to Health Canada submissions or experience compiling CTD/eCTD dossiers for regulated markets is an advantage.
• Knowledge of ICH guidelines (Q1A, Q2, Q3A/B, Q6A, Q11), pharmacopeial standards, and analytical method validation practices.

Relevant courses (comma‑separated):

M.Pharm (Pharmaceutics), B.Pharm, Diploma in Regulatory Affairs, Postgraduate Diploma in Pharmaceutical Regulatory Affairs, Certificate in Drug Development and Regulatory Science, M.Sc. Pharmaceutical Sciences, PG Diploma in Quality Assurance, Certificate in GMP & Validation

Location & Salary

Location: Bachupally, Telangana — the role is primarily on‑site to facilitate close coordination with laboratory teams, manufacturing and quality functions.

Salary & Benefits: Competitive and commensurate with experience. Aurobindo offers market‑aligned pay, performance incentives, health benefits and other standard employee perks. Final compensation will be discussed with shortlisted candidates depending on experience and skill set.

Application Process

To apply, email your CV and a short cover note to: Sreeja.Yangam@aurobindo.com

Email subject line: Application – Regulatory Affairs – CA market

Application checklist:

• Updated CV highlighting formulation projects, stability studies, analytical validations and any CMC/CTD contributions.
• A concise 2–3 line cover note summarizing your most relevant experience and why you’re a strong fit.
• Optionally, indicate current and expected salary.

Shortlisted candidates will be contacted for a technical interview (focused on CMC and dossier strategy) followed by HR discussion and final selection.

How this role advances healthcare & pharma quality

Regulatory Affairs professionals are guardians of product quality and patient safety. By ensuring that scientific data from formulation development and stability studies are accurately and transparently presented to regulators, you enable timely approvals and maintain public trust. Accurate CMC documentation reduces approval delays, mitigates post‑market risks, and ensures reliable product supply — all of which directly benefit patients and healthcare systems.

Working on Canada market dossiers offers exposure to international regulatory expectations and strengthens your ability to design global CMC strategies that comply with stringent regulatory frameworks.

Key Selling Points — Why Apply

• Join a globally recognized pharmaceutical organization with a strong track record in regulated markets.
• Strengthen your CMC and dossier compilation expertise with hands‑on responsibility for Health Canada submissions.
• Work cross‑functionally with R&D, QC, QA and Manufacturing to broaden technical knowledge and regulatory perspective.
• Opportunity to grow into senior or regional regulatory roles with exposure to lifecycle management and global submissions.
• Be part of work that directly impacts patient safety and medication availability in international markets.

FAQs — Frequently Asked Questions

Q: What is the minimum educational qualification?
A: M.Pharm (Pharmaceutics) is preferred. Candidates with B.Pharm plus strong hands‑on formulation and dossier experience may be considered.

Q: How many vacancies are available?
A: One (1) vacancy for Regulatory Affairs – Canada Market (Quality/CMC Module).

Q: Is remote work available?
A: This is primarily an on‑site role at Bachupally due to the technical collaboration required with labs and manufacturing. Hybrid options may be discussed based on company policy.

Q: What should I include in my application?
A: Updated CV, a 2–3 line cover note focusing on relevant dossier or technical experience, and optionally current/expected salary.

Q: Will Aurobindo provide visa sponsorship to work in Canada?
A: This role supports regulatory submissions for the Canada market and is based in India. Visa sponsorship for relocation is not typically part of the hiring process; discuss specifics during the interview if required.

Q: How will my dossier experience be evaluated?
A: Recruiters will look for specific CMC sections you authored or reviewed, experience in stability interpretation, analytical validations, and any direct involvement in regulatory submissions or queries.

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Category	Details
Company	Aurobindo Pharma
Vacancies	Regulatory Affairs – Canada Market (Quality Module)
Required Education	M.Pharm (Pharmaceutics) preferred; B.Pharm may be considered
Experience	3–5 Years (Formulation R&D / Regulatory Affairs / CMC Documentation)
Location	Bachupally, Telangana