TAPI Hiring Regulatory Affairs Specialist – DMF & eCTD Submissions

TAPI Hiring Regulatory Affairs Specialist – DMF & eCTD Submissions | 3–5 Years Experience | Sadar, Uttar Pradesh

TAPI is inviting applications for the position of Regulatory Affairs Specialist at its Sadar, Uttar Pradesh location. This is a full-time opportunity for experienced regulatory professionals with 3–5 years of experience in pharmaceutical regulatory affairs, particularly in Drug Master File (DMF) management and electronic submissions (eCTD).

This role sits within the Regulatory Affairs (RA) department and focuses on global API registrations, lifecycle management, and regulatory compliance support. If you have a Master’s degree in Science, Chemistry, or Life Sciences and hands-on exposure to pharmaceutical submissions, this position offers strong growth within the global active pharmaceutical ingredient (API) sector.

---

Company Overview

TAPI is recognized as one of the world’s leading suppliers of active pharmaceutical ingredients (APIs), partnering with approximately 80% of the top 50 global pharmaceutical companies. With a legacy of more than 80 years and a portfolio exceeding 350 API products, TAPI plays a critical role in global drug manufacturing and pharmaceutical supply chains.

The company operates 13 advanced manufacturing facilities across Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. With a workforce of over 4,200 professionals worldwide, TAPI combines innovation, regulatory excellence, and high-quality manufacturing standards to deliver pharmaceutical raw materials and custom CDMO solutions.

Working at TAPI means contributing to global healthcare by ensuring regulatory compliance and uninterrupted supply of APIs that form the backbone of essential medicines.

---

Job Role & Responsibilities

The Regulatory Affairs Specialist will primarily support RA associates in administrative and technical activities related to global registrations, electronic submissions, and customer regulatory support.

Key Responsibilities

• Prepare and maintain electronic Common Technical Document (eCTD) submissions for Drug Master Files using publishing systems as per international regulatory guidelines.
• Submit DMFs prepared by the Regulatory Affairs team to global health authorities in accordance with regional requirements.
• Provide administrative and technical support for DMF lifecycle management and regulatory maintenance activities.
• Respond to customer regulatory queries by sharing DMFs, Certificates of Suitability (CEPs), and deficiency letter responses via CRM systems.
• Upload, track, and manage regulatory documents within CRM and Smarteam systems.
• Distribute customer notifications prepared by the RA team through structured regulatory communication channels.
• Work across multiple submission gateways and authority-specific portals simultaneously.
• Continuously learn global submission guidelines and internal regulatory workflows.

This position requires accuracy, compliance awareness, and the ability to manage multiple regulatory submissions within strict timelines.

---

Eligibility / Qualifications

Educational Qualification

Master’s degree in Science, Chemistry, Life Sciences, or related field.

Relevant Courses: M.Sc Chemistry, M.Sc Organic Chemistry, M.Sc Analytical Chemistry, M.Sc Life Sciences, M.Pharm, B.Pharm, Pharmaceutical Chemistry, Regulatory Affairs, Industrial Pharmacy, Biotechnology, Biochemistry.

Experience

• 3–5 years of experience in pharmaceutical regulatory affairs.
• Prior experience in DMF preparation, maintenance, and eCTD submissions is strongly preferred.
• Experience working in a pharmaceutical or API manufacturing company is an advantage.

Required Skills

• Strong understanding of global regulatory submission processes.
• Working knowledge of DMF, CEP, and deficiency response handling.
• Familiarity with eCTD publishing systems and regulatory gateways.
• Proficiency in CRM tools and document management systems.
• Good professional command of English (written and spoken).
• Excellent organizational and time management skills.
• Ability to work independently and collaboratively in cross-functional teams.
• High service orientation toward internal and external stakeholders.

Candidates with exposure to international regulatory authorities and API regulatory documentation will have an added advantage.

---

Location & Employment Details

Location: Sadar, Uttar Pradesh, India
Job Type: Full-Time
Department: Regulatory Affairs
Industry: Active Pharmaceutical Ingredients (API) Manufacturing

---

Application Process

Interested candidates can apply through the official LinkedIn job posting link below:

Apply Here:
https://www.linkedin.com/jobs/view/4380508318/

Applicants should ensure their resume clearly highlights regulatory submission experience, DMF handling exposure, and eCTD publishing expertise.

---

Frequently Asked Questions (FAQs)

1. Who can apply for the Regulatory Affairs Specialist role at TAPI?

Candidates with a Master’s degree in Science or Chemistry and 3–5 years of pharmaceutical regulatory experience can apply.

2. Is prior DMF experience mandatory?

Yes. Experience in DMF preparation and electronic submissions is strongly preferred.

3. Is this role suitable for freshers?

No. A minimum of 3 years of regulatory experience is required.

4. What systems should candidates be familiar with?

Candidates should understand eCTD publishing tools, CRM systems, and regulatory submission gateways.

5. What career growth opportunities are available?

Professionals can progress into Senior Regulatory Affairs Specialist, Regulatory Manager, Global Regulatory Lead, or API Compliance Head roles.

---

Recruitment Summary

Company	TAPI
Vacancies	Regulatory Affairs Specialist
Required Education	Master’s Degree in Science, Chemistry, Life Sciences or Related Field
Experience	3–5 Years in Pharmaceutical Regulatory Affairs & DMF Submissions