Aurore Pharma Hiring Regulatory Affairs (RA) – Only Male Candidates

Aurore Pharmaceuticals Private Limited, a rapidly growing API (Active Pharmaceutical Ingredient) manufacturer with a global outlook, is seeking experienced and detail-oriented professionals for the position of **Executive/Officer/Sr. Officer** in their **Regulatory Affairs (RA)** department. This is an excellent opportunity for candidates with a background in pharmaceutical sciences and regulatory markets to join a dynamic team in Hyderabad. Please note that this position is exclusively for **male candidates**.

Career Opportunity in Regulatory Affairs at Aurore Pharmaceuticals, Hyderabad

Join Aurore Pharmaceuticals and play a crucial role in ensuring the compliance of our APIs with global regulatory standards. As a Regulatory Affairs professional, you will be responsible for preparing and managing registration dossiers for various international markets, contributing to the efficient and timely approval of our products. This role offers a chance to work with diverse regulatory requirements and contribute to the company’s global expansion.

About Aurore Pharmaceuticals Private Limited

Aurore Pharmaceuticals Private Limited is a pure-play API manufacturer with a diverse portfolio of capabilities aimed at delivering efficiencies for generic pharmaceuticals globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, Aurore Pharmaceuticals is committed to quality and innovation in API manufacturing. Our focus on global regulatory compliance ensures that our products meet the highest international standards.

Job Title

Executive/Officer/Sr. Officer – Drug Regulatory Affairs

Experience

1-5 Years of experience in Regulatory Markets (EU/MHRA/USFDA).

Qualification

MSc Chemistry / M Pharmacy / B Pharmacy.

Walk-In Interview Details

Date

12-05-2025 to 17-05-2025

Time

9:00 AM – 5:00 PM

Venue

Aurore Pharmaceuticals Private Limited
Plot no: 35,36,38 to 40,49 to 51
Phase IV IDA Jeedimetla
Hyderabad

Responsibilities

Preparation and review of registration dossiers as per CTD/ACTD and country-specific formats.
Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines compliance.
Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.
Co-ordination with clients for the tracking and status update of project plans.
Preparation of response to queries raised by regulatory authorities as well as by clients.
Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders.
Literature search/survey to compile clinical and non-clinical part within registration dossiers.
Preparation and review of SPC, Product monograph, package insert and labeling information.
Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC.
Involved in preparation of renewal application for certificates like GMP, CPP, WHO-GMP, GLP & Non-Conviction Certificate.

Important Note for Male Candidates

Please be aware that this particular recruitment drive is specifically for **male candidates** only.

Documents to Carry

All interested and eligible male candidates are requested to bring the following documents for the walk-in interview:

Your updated CV (Curriculum Vitae).
Last 3 months payslips.
Increment letter.
All relevant educational certificates and mark sheets (original and photocopies).
Identity proof (Aadhar card, PAN card, etc.).

For More Information

For any further information or queries, please contact:

Phone: 7095135051 / 7095170028

Website: www.aurorepharma.com

We encourage all qualified male candidates with the relevant experience to attend the walk-in interview at Aurore Pharmaceuticals in Hyderabad. This is a great opportunity to advance your career in the growing pharmaceutical industry.