Regulatory Affairs Jobs – Piramal Pharma Solutions (PPS), a global CDMO leader, is hiring an Executive – Regulatory Affairs in Navi Mumbai, Maharashtra.
This role offers a strong opportunity for chemistry graduates with a focus on peptide or API regulatory submissions to join a high-growth organization supporting end-to-end drug development and manufacturing for innovators worldwide.
Contents
About the Company
Piramal Pharma Solutions (PPS) is a leading Contract Development and Manufacturing Organization (CDMO) under Piramal Pharma Limited, providing comprehensive services across the drug life cycle—from discovery to commercial supply.
With a globally integrated network of facilities in North America, Europe, and Asia, PPS specializes in APIs, finished dosage forms, highly potent APIs, antibody-drug conjugates, sterile fill/finish, peptides, and biologics (including vaccines, gene therapies, and monoclonal antibodies).
The company is trusted by global innovators and generic firms for its regulatory expertise, complex technology capabilities, and commitment to quality, compliance, and timely delivery.
Job Details
- Company Name: Piramal Pharma Solutions (PPL)
- Position: Executive – Regulatory Affairs
- Experience: Relevant experience in regulatory submissions (specific years not mentioned; suitable for 1–5 years)
- Qualification: Master’s / Bachelor’s degree in Chemistry or related field
- Location: Navi Mumbai, Maharashtra, India
- Work Type: On-site
- Travel: Low
Job Description
The Executive – Regulatory Affairs role supports regulatory compliance and submission activities for APIs and related products. The position focuses on database maintenance, document compilation, and coordination with global regulatory agencies (FDA and CDSCO), playing a key part in ensuring timely approvals, amendments, and license applications in a fast-paced CDMO environment.
Executive – Regulatory Affairs
- Department: Regulatory Affairs
- Market: Pharmaceuticals – CDMO & API
- Role: Executive
- Experience: Relevant experience in regulatory submissions
- Education/Qualification: Master’s / Bachelor’s degree in Chemistry or related field
Skills/Qualifications
- Basic understanding of peptide synthesis principles (preferred but not mandatory)
- Strong attention to detail and commitment to quality and accuracy
- Proficiency in regulatory database management and document compilation
- Knowledge of FDA and CDSCO submission requirements
- Ability to coordinate cross-functional teams and manage timelines
- Excellent communication, interpersonal, and organizational skills
- Willingness to learn and adapt to evolving regulatory processes
Key Responsibilities
- Maintain and update regulatory databases to track submissions and status
- Support compilation of Applicant’s part for regulatory dossiers
- Prepare Letters of Access (LoA) for regulatory filings
- Collect and organize documents for annual updates, amendments, and CEP amendments
- Gather required documentation for license applications to FDA and CDSCO
- Coordinate with internal teams for timely availability of regulatory information
- Perform any other regulatory support tasks assigned by Head of Department
Benefits/Perks
- Career growth in a globally integrated CDMO leader
- Exposure to regulatory filings for APIs and complex molecules
- Learning opportunities in FDA/CDSCO compliance and peptide/API regulations
- Supportive, inclusive work culture with focus on quality and innovation
- Competitive compensation and benefits package
- Opportunity to contribute to life-changing medicines
How to Apply
Send your updated resume highlighting regulatory experience and chemistry background to the official HR email (check the Piramal careers portal or original posting for the latest contact). Apply directly through the Piramal careers page or job portal using Job ID 10236.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Piramal Pharma Career page.
For more regulatory affairs jobs, CDMO opportunities, API regulatory roles, and pharma careers in Navi Mumbai/Maharashtra, visit Pharma Recruiter.
Apply now and join Piramal Pharma Solutions in advancing global drug development!
Why You Should Join
Piramal Pharma Solutions offers a dynamic, globally connected environment ideal for regulatory professionals passionate about API and peptide submissions.
With a strong network of facilities, expertise across complex modalities, and a commitment to inclusive growth, the company provides meaningful work, regulatory exposure, career advancement, and the chance to contribute to innovative therapies.
Joining Piramal means being part of a values-driven organization that balances organic and inorganic growth while prioritizing quality, ethics, and employee development.
FAQs
What qualification is required for the Executive – Regulatory Affairs role at Piramal?
Master’s or Bachelor’s degree in Chemistry or a related field; basic understanding of peptide synthesis is a plus.
Is prior regulatory experience mandatory?
Relevant experience in regulatory submissions (FDA/CDSCO) is expected; the role suits candidates with 1–5 years in API/CDMO regulatory support.
Where is the job located?
Navi Mumbai, Maharashtra – at Piramal Pharma Solutions’ regulatory and operational hub.
What growth opportunities exist in regulatory affairs at Piramal?
Strong potential for progression in a global CDMO with exposure to FDA/CDSCO filings, peptide/API projects, and cross-functional collaboration in a fast-growing organization.
