Accuprec Research Hiring Sr Research Associate (Regulatory)

M.Pharm Sr Research Associate (Regulatory) – Ahmedabad

M.Pharm (Regulatory Affairs) — 1 opening for Sr Research Associate, 4–5 yrs EU/Asia experience, Ahmedabad. Immediate joiners.

Accuprec Research Labs Pvt. Ltd. invites experienced regulatory professionals with M.Pharm (Regulatory Affairs) to apply for a senior research associate role based in Ahmedabad. This position targets candidates with hands‑on experience in European and Asian regulatory pathways, ideally with prior EU market exposure. The role is for immediate joining and offers a chance to shape dossier strategy, ensure compliance for international submissions, and strengthen Accuprec’s regulatory footprint.

Company Overview

Accuprec Research Labs Pvt. Ltd. is an established contract research and development organization focused on delivering regulatory, analytical and formulation solutions to pharmaceutical clients. With a reputation for technical rigour and compliance, Accuprec supports product registrations, dossier preparation, and regulatory liaison across multiple global markets. Working here means exposure to end‑to‑end regulatory processes that directly affect product approvals and patient access.

Why this role matters

Regulatory Affairs professionals translate complex scientific data into the regulatory language required for market approvals. This senior research associate role will contribute to high‑impact submissions for the EU and Asian markets — ensuring dossiers meet regional standards, that CMC documentation is robust, and that regulatory risks are anticipated and mitigated. Strong performance in this role shortens approval timelines and improves the chances of successful market access.

Job Role & Responsibilities

• Prepare, review and manage regulatory dossiers for European and Asian submissions (CTD/eCTD formats).
• Draft and edit CMC sections, quality summaries, stability reports and regulatory cover letters.
• Coordinate with cross‑functional teams (R&D, QC, Production, QA) to gather data required for filings.
• Perform gap analysis and develop regulatory strategies for new filings and life‑cycle management.
• Respond to regulatory authority queries and support dossier clarifications during review cycles.
• Maintain and update regulatory files, submission trackers, and correspondence logs.
• Monitor regulatory intelligence for EU and Asian markets, interpreting guidance and advising on impact.
• Support regulatory inspections and audit responses where required.
• Mentor junior regulatory staff and contribute to process improvements in dossier compilation workflows.

Eligibility / Qualifications

• Qualification: M.Pharm in Regulatory Affairs (mandatory).
• Experience: 4–5 years in Regulatory Affairs with demonstrable experience in European and Asian markets; direct EU market exposure preferred.
• Technical skills: Strong CMC writing skills, familiarity with CTD/eCTD submission formats, stability data interpretation, and regulatory intelligence.
• Soft skills: Precise technical writing, stakeholder management, project coordination, and deadline orientation.

Location & Compensation

• Location: Ahmedabad (Accuprec Research Labs Pvt. Ltd.).
• Joining: Immediate joiners preferred.
• Positions: Senior Research Associate — Regulatory Affairs (EU & Asia focus).
• Salary: Competitive; specify current in‑hand and expected CTC in application (as requested by recruiter).

Application Process

Interested candidates should email their CV with salary details and availability to:
career@accuprec.in

Application checklist:

• Updated CV highlighting regulatory filings and EU/Asia submissions.
• One‑page summary of two key dossiers you contributed to (role, sections authored, outcome).
• In‑hand salary, expected salary, and earliest joining date.

Contact for inquiries: +91 76001 38060 / +91 90999 32105

Selection Process & Interview

• Resume shortlisting based on EU/Asia dossier experience and CMC writing samples.
• Technical interview focusing on CTD/eCTD preparation, stability data interpretation, and case studies on dossier queries.
• Final discussion on compensation and joining timelines.

FAQs

Q: How many openings are available?
A: The posting specifies openings for the Ahmedabad location; applicants should clarify exact vacancy count during the application.

Q: Is M.Pharm in Regulatory Affairs mandatory?
A: Yes — M.Pharm (Regulatory Affairs) is the required qualification for this senior role.

Q: Can B.Pharm holders apply?
A: B.Pharm graduates with strong regulatory experience may be considered only if they meet the role’s technical expectations; M.Pharm is preferred.

Q: Is EU market experience essential?
A: EU market exposure is explicitly mentioned as part of the required experience. Candidates with documented EU dossier work will be prioritized.

Q: What should I include in my application email?
A: CV, a one‑page dossier/project summary, current in‑hand salary, expected salary, and earliest joining date.

Q: Is this role open to immediate joiners only?
A: Immediate joiners are preferred but candidates with notice periods can still apply if they have relevant experience.

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+----------------------+-------------------------------------------------------------+
| Company              | Accuprec Research Labs Pvt. Ltd.                            |
+----------------------+-------------------------------------------------------------+
| Vacancies            | Sr Research Associate — Regulatory Affairs (EU/Asia focus)  |
+----------------------+-------------------------------------------------------------+
| Required Education   | M.Pharm (Regulatory Affairs)                                |
+----------------------+-------------------------------------------------------------+
| Experience           | 4–5 years (EU & Asia regulatory experience preferred)        |
+----------------------+-------------------------------------------------------------+