Piramal Pharma Limited, a leading global pharmaceutical company known for its innovation in API manufacturing and complex generics, is actively recruiting experienced professionals for a key role in its Regulatory Affairs department. The company is seeking talented individuals for the position of Deputy Manager / Manager – Regulatory Affairs, with a special invitation to professionals looking to restart or reboot their careers.
This opportunity is based in Navi Mumbai, India, and focuses on handling regulatory submissions for regulated markets including the US, Europe, and others. With Piramal’s strong emphasis on quality, compliance, and patient-centric solutions, this role offers a chance to contribute to impactful work in the pharmaceutical industry.
If you have solid experience in global regulatory requirements and are passionate about ensuring compliance for APIs and peptides, this could be the perfect next step in your career.
Key Responsibilities
The selected candidate will play a critical role in managing regulatory activities end-to-end. Primary duties include:
- Compiling, reviewing, and submitting regulatory dossiers and submissions, including eCTD format, for the US (FDA), Europe (EU), CDSCO, and other regulated markets.
- Managing Drug Master Files (DMFs), covering preparation, review, updates, and full lifecycle management.
- Maintaining and updating regulatory databases for new submissions, lifecycle changes, regulatory responses, LOAs (Letters of Authorization), Applicant Parts, and Restricted Parts.
- Planning, scheduling, and submitting annual reports, amendments, variations, and other changes in line with regulatory timelines.
- Preparing, reviewing, and submitting responses to queries from regulatory authorities and customers.
- Issuing No Objection Certificates (NDCs) and ensuring timely updates to internal regulatory databases.
- Reviewing and approving change controls, deviations, and required QMS (Quality Management System) documentation.
This position demands strong attention to detail, project management abilities, and the capacity to handle complex regulatory challenges in a fast-paced environment.
Required Qualifications and Experience
Piramal Pharma is looking for candidates with the following profile:
- Educational Qualification: M.Sc / M.Pharm / B.Pharm
- Experience: 8–15 years in Regulatory Affairs, specifically within API / Peptides manufacturing.
- Key Competencies:
- Strong expertise in global regulatory requirements (US FDA, EU, CDSCO) and DMF submissions.
- Proven experience in APIs and Peptides.
- Excellent analytical, communication, and leadership skills.
The company is open to applications from professionals eager to restart their careers, making it an inclusive opportunity for those returning to the workforce.
Salary, Benefits, and How to Apply
While the exact salary package will depend on experience and negotiation, similar managerial roles in Regulatory Affairs at leading pharma companies in the Mumbai/Navi Mumbai region typically range from ₹15–30 lakhs per annum (indicative, based on industry standards for 8–15 years of experience).
Piramal Pharma offers competitive compensation, performance incentives, health benefits, professional development opportunities, and a supportive work culture focused on “Design Your Destiny.”
To apply, send your updated CV to: Shreelaxmi.Kareepadath@piramal.com
