Location
Thane West, Wagle Estate, Maharashtra, India
Job Category
- Healthcare & Medical
- Science & Research
- Engineering & Technical
- Manufacturing & Production
- Operations & Supply Chain
- Private Jobs
Job Overview
An exciting opportunity is available for experienced pharmaceutical regulatory professionals specializing in API Regulatory Affairs. This role is designed for candidates with strong expertise in regulatory submissions, compliance documentation, and lifecycle management within the pharmaceutical manufacturing industry.
The position offers long-term career growth for professionals experienced in Drug Master File (DMF), ASMF, CEP, CTD, and eCTD submissions. Candidates will work closely with cross-functional departments including R&D, QA, QC, Production, and Marketing to support regulatory compliance and documentation processes for global pharmaceutical markets.
This role provides valuable exposure to international regulatory standards, technical documentation management, plant audit coordination, and professional development in API regulatory operations. Professionals seeking advancement in pharmaceutical regulatory affairs and compliance management will find strong career progression opportunities in this position.
Key Responsibilities
- Prepare and compile DMF, ASMF, and CEP documentation in CTD/eCTD format
- Manage lifecycle maintenance, change controls, and regulatory submissions
- Handle regulatory authority queries and customer documentation requests
- Prepare amendment reports, annual updates, and technical regulatory packages
- Coordinate with R&D, QA, QC, Production, and Marketing departments
- Review validation documents, Batch Manufacturing Records (BMR), and regulatory documentation
- Conduct regular plant visits for audits, documentation reviews, and CAPA follow-up activities
- Ensure compliance with international pharmaceutical regulatory requirements
- Manage multiple regulatory submissions and documentation timelines efficiently
Requirements & Qualifications
- Minimum 3 to 7 years of experience in API Regulatory Affairs within a pharmaceutical company
- Candidates from only QA, QC, or Formulation backgrounds will not be considered
- Strong expertise in DMF, CEP, CTD, and eCTD submissions
- Knowledge of EDQM, Europe, and ROW pharmaceutical market regulations
- Good communication, coordination, and technical documentation skills
- Ability to manage regulatory timelines and multiple submissions simultaneously
- Comfortable with frequent plant visits to Vadodara, Gujarat
- Experience in regulatory compliance and pharmaceutical documentation management preferred
Salary, Benefits & Career Growth
- Compensation: Up to ₹7 LPA
- Company-sponsored travel expenses for plant visits
- Opportunity to work on international pharmaceutical regulatory submissions
- Career growth in API Regulatory Affairs and compliance management
- Exposure to EDQM, Europe, and ROW market regulations
- Professional development through cross-functional collaboration and technical regulatory projects
- Experience in global regulatory documentation and audit coordination
- Preference for immediate joiners or candidates with less than 2 months’ notice period
Application Process
Application Process (Website):
Apply only through the official job link
Click Apply Now on the website
HR Email for Application
📩 Interested candidates can WhatsApp their updated resume directly to:
8169237911