Aurobindo Pharma: Regulatory Affairs Openings in Hyderabad
Summary:
Aurobindo Pharma, a leading pharmaceutical company, is seeking motivated and talented individuals to join our Regulatory Affairs team at our APLRC1 facility in Bachupally, Hyderabad. We are looking for both fresh M.Pharm (Pharmacology) graduates and experienced Regulatory Affairs professionals with a focus on Module 1 (M1) documentation for EU and Canada markets. This is an excellent opportunity to contribute to a global pharmaceutical organization and advance your career in regulatory affairs.
Job Title: Regulatory Affairs Associate/Specialist
Department: Regulatory Affairs
Location: APLRC1, Bachupally, Hyderabad
About Aurobindo Pharma:
Aurobindo Pharma is a globally recognized pharmaceutical company committed to developing, manufacturing, and marketing high-quality, affordable medicines. We strive to improve the health and well-being of people worldwide through innovation and a dedication to excellence. At Aurobindo, we foster a supportive and learning-focused environment where our employees can thrive and reach their full potential.
Job Description:
We are seeking a detail-oriented and enthusiastic Regulatory Affairs Associate/Specialist to join our team. The successful candidate will be responsible for preparing, reviewing, and compiling regulatory submissions for the EU and Canada markets, ensuring compliance with global regulatory guidelines, and supporting the lifecycle management of regulatory dossiers.
Responsibilities:
- Prepare, review, and compile regulatory submissions for EU and Canada markets, including new product registrations, variations, and renewals.
- Manage and maintain Module 1 (M1) documentation, ensuring accuracy and completeness.
- Ensure compliance with global regulatory guidelines, including EU and Canadian regulations, and internal Standard Operating Procedures (SOPs).
- Coordinate with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D), to gather necessary information for regulatory submissions.
- Support the lifecycle management of regulatory dossiers, including tracking regulatory updates and ensuring timely submission activities.
- Stay updated on changes in regulatory requirements and guidelines and communicate these changes to relevant stakeholders.
- Assist in the preparation and review of responses to regulatory agency queries.
- Maintain accurate records of all regulatory activities.
- Contribute to the development and improvement of regulatory processes and procedures.
Qualifications:
- M.Pharm in Pharmacology (Fresh graduates are encouraged to apply).
- 0-3 years of experience in Regulatory Affairs.
- Preferred experience in EU/Canada submissions and M1 document preparation and review.
- Strong knowledge of regulatory guidelines and dossier requirements, particularly for EU and Canada.
- Excellent communication skills, both written and verbal.
- Strong documentation skills and attention to detail.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite.
Benefits of Working at Aurobindo Pharma:
- Opportunity to grow your career in a top global pharmaceutical company.
- Exposure to international regulatory submissions and diverse regulatory environments.
- Supportive work environment and learning-focused culture.
- Competitive salary and benefits package, commensurate with experience.
- Opportunities for professional development and training.
- Contribution to the development and delivery of essential medicines.
How to Apply:
If you are a motivated and qualified individual seeking a challenging and rewarding career in Regulatory Affairs, we encourage you to apply. Please submit your updated CV to [email protected].
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
We look forward to receiving your application!