Executive – Regulatory Affairs
Location: Navi Mumbai, Maharashtra, India
Department: Regulatory Affairs
Business Unit: Piramal Pharma Limited (PPL)
Travel Requirement: Low
Job Overview
Piramal Pharma Limited (PPL) is seeking a detail-oriented Executive – Regulatory Affairs to support regulatory operations and submissions for global and domestic markets. The role focuses on maintaining regulatory databases, coordinating documentation for regulatory filings, and ensuring compliance with FDA, CDSCO, and other relevant regulatory authorities. The ideal candidate will have experience in regulatory affairs or pharmaceutical operations, strong organizational skills, and a commitment to quality.
Key Responsibilities
Maintain and update regulatory databases to track submissions, amendments, and license applications.
Support compilation of regulatory documents for domestic and global submissions, including Applicant’s part of dossiers.
Prepare Letters of Access and manage related documentation.
Collect and organize documents for annual updates, regulatory amendments, and CEP submissions.
Coordinate submissions and license applications with FDA and CDSCO.
Perform other duties as assigned by the Head of Department (HOD) or designee.
Minimum Qualifications & Experience
Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
1-3 years of experience in regulatory affairs, documentation management, or pharmaceutical compliance is preferred.
Familiarity with regulatory submission processes for APIs, drug products, or clinical documentation.
Knowledge of peptide synthesis principles is a plus.
Skills & Competencies
Strong attention to detail and commitment to maintaining high-quality standards.
Effective communication and interpersonal skills.
Ability to work collaboratively in a team-oriented environment.
Willingness to learn, adapt, and implement new regulatory processes.
Proficient in document management systems and standard office software.
About Piramal Pharma Solutions (PPS)
Piramal Pharma Solutions (PPS) is a leading Contract Development and Manufacturing Organization (CDMO) delivering end-to-end solutions across the pharmaceutical life cycle. With a globally integrated network in North America, Europe, and Asia, PPS offers services including drug discovery, process and pharmaceutical development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms. PPS specializes in complex technologies such as highly potent APIs, peptides, antibody-drug conjugates, sterile fill/finish, and biologics, including vaccines, gene therapies, and monoclonal antibodies. Our global expertise and trusted service make PPS a partner of choice for innovators and generic pharmaceutical companies worldwide.
Equal Employment Opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action Employer. Employment decisions are based on merit, qualifications, skills, and achievements without discrimination based on race, religion, color, gender, sexual orientation, age, disability, or other legally protected characteristics. We provide reasonable accommodations for qualified individuals with disabilities and support diverse religious practices.
Why Join Us
This role offers an opportunity to gain hands-on experience in regulatory affairs within a leading CDMO, contribute to global submissions, and advance your career in pharmaceutical regulatory strategy.
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