TAPI is inviting applications for the position of Regulatory Affairs Specialist in Sadar, Uttar Pradesh, India. This opportunity is ideal for professionals with experience in pharmaceutical regulatory affairs, Drug Master Files (DMF), and electronic submissions (eCTD).
TAPI is recognized as one of the world’s leading suppliers of active pharmaceutical ingredients (APIs), partnering with 80% of the top 50 pharmaceutical companies worldwide. With over 80 years of industry expertise and more than 350 API products, the company continues to expand its regulatory and scientific workforce globally.
If you are seeking pharma regulatory affairs jobs in India, particularly in DMF submissions, regulatory documentation, and API regulatory compliance, this role offers strong career growth within a global pharmaceutical organization.
Job Overview
- Position: Regulatory Affairs Specialist
- Company: TAPI
- Location: Sadar, Uttar Pradesh, India
- Job Type: Full-time
- Experience Required: 3–5 Years
- Industry: Pharmaceutical / Active Pharmaceutical Ingredients (API)
This regulatory affairs job in India focuses on supporting regulatory documentation, Drug Master File (DMF) submissions, and communication with regulatory authorities and pharmaceutical customers.
Key Responsibilities
The Regulatory Affairs Specialist will support regulatory operations and ensure compliance with global pharmaceutical submission standards.
Primary responsibilities include:
- Preparing and maintaining electronic submissions (eCTD) for Drug Master Files (DMFs) using publishing systems.
- Submitting regulatory dossiers and DMF documentation to global regulatory authorities according to industry guidelines.
- Supporting Regulatory Affairs Associates with administrative and regulatory documentation activities.
- Responding to customer regulatory requests, including providing DMFs, CEPs, and deficiency response documentation via CRM systems.
- Maintaining regulatory documents within CRM and Smarteam systems.
- Distributing customer regulatory notifications prepared by the regulatory affairs team.
- Learning and applying global regulatory submission guidelines and processes.
- Managing submissions across multiple regulatory gateways and authority systems.
Required Qualifications
Candidates applying for this pharmaceutical regulatory affairs job should meet the following criteria:
- Master’s Degree in:
- Chemistry
- Life Sciences
- Pharmaceutical Sciences
- Related scientific discipline
- 3–5 years of experience in:
- Pharmaceutical regulatory affairs
- API regulatory documentation
- Drug Master File (DMF) submissions
- eCTD publishing systems
Key Skills
Successful candidates should demonstrate:
- Strong communication and collaboration skills
- Ability to work in cross-functional regulatory teams
- Knowledge of pharmaceutical regulatory submission systems
- Excellent organizational and time management abilities
- Strong customer support orientation
- Adaptability to evolving regulatory compliance processes
- Good professional English communication skills
Why Join TAPI?
Working at TAPI provides exposure to global pharmaceutical regulatory systems and API manufacturing networks.
Key advantages include:
- Work with a global API leader serving top pharmaceutical companies
- Exposure to international regulatory submissions
- Opportunity to handle Drug Master Files and global compliance documentation
- Collaborative environment with 4,200+ professionals worldwide
- Career growth in pharmaceutical regulatory affairs and API regulatory compliance
TAPI operates 13 advanced manufacturing and R&D facilities across Europe, Israel, Mexico, and India, making it a strong platform for professionals seeking international pharmaceutical regulatory experience.