Regulatory Executive Jobs at Zenith Drugs in Indore for experienced pharma professionals handling CTD ACTD dossiers and global registrations.
Company Overview
Zenith Drugs is a rapidly growing pharmaceutical manufacturing and trading organization headquartered in Indore, Madhya Pradesh. Established in 2000, the company has built a strong presence in branded, generic, and OTC pharmaceutical segments with a diverse product portfolio that includes oral solids, liquid orals, externals, injectables, and specialty dosage forms. Zenith Drugs is focused on quality, safety, affordability, and regulatory compliance while expanding its footprint across international markets. With ambitious growth plans and preparations toward future public listing, the company offers a stable and forward-looking environment for experienced regulatory professionals. Regulatory Executive Jobs at Zenith Drugs
Job Location & Employment Type
- Job Location: Indore, Madhya Pradesh
- Employment Type: Full-Time
- Work Mode: Onsite
- Industry: Pharmaceutical Manufacturing & Exports
Open Positions / Department Details
- Position: Regulatory Executive
- Department: Regulatory Affairs – International Markets
- Experience Level: Mid-Level (4 to 6 Years)
This role is designed for regulatory professionals who have hands-on exposure to international product registrations and dossier management across emerging and regulated markets. Regulatory Executive Jobs at Zenith Drugs
Key Roles & Responsibilities
The Regulatory Executive will be responsible for managing end-to-end regulatory activities related to global product registrations, variations, and compliance for multiple international markets. Regulatory Executive Jobs at Zenith Drugs
- Prepare, compile, and submit registration, re-registration, renewal, and variation dossiers for global markets.
- Develop and maintain Finished Product Dossiers in CTD and ACTD formats for a wide range of dosage forms including tablets, capsules, injectables, eye/ear drops, dry syrups, suspensions, sachets, and pre-filled syringes.
- Ensure all dossiers meet country-specific regulatory guidelines and submission requirements.
- Review packaging artworks and labeling materials to confirm compliance with local regulatory and language requirements.
- Coordinate closely with Marketing and internal stakeholders to collect dossier inputs, respond to regulatory queries, and track registration progress.
- Arrange dispatch of product samples, stability data, and supporting documents required for regulatory submissions.
- Review Drug Master Files (DMFs) and coordinate with API manufacturers and vendors to address regulatory deficiencies or authority queries.
- Maintain comprehensive regulatory trackers, submission timelines, aging analysis, and archival documentation for all products and markets.
- Prepare and submit GMP applications and supporting documents for multiple international regulatory authorities within defined timelines.
- Handle tender-related regulatory documentation for government and institutional tenders, particularly in African markets such as Ethiopia and Kenya.
- Participate in monthly planning meetings, regulatory reviews, and management discussions to support business expansion strategies.
- Ensure continuous compliance with evolving international regulatory requirements and support audit readiness.
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy or Life Sciences is mandatory.
Experience
- 4 to 6 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Practical exposure to international markets such as Southeast Asia, Africa, LATAM, and CIS countries is strongly preferred.
Skills Required
- Strong knowledge of CTD/ACTD dossier preparation, variations, and lifecycle management.
- Experience handling country-specific regulatory submissions and compliance activities.
- Good understanding of labeling, artwork review, and regulatory documentation processes.
- Proficiency in Microsoft Word, Excel, and PowerPoint for regulatory documentation and reporting.
- Excellent written and spoken English communication skills.
- Strong organizational skills with the ability to manage multiple submissions and timelines simultaneously.
- Capability to work independently while coordinating with cross-functional teams.
Regulatory Executive Jobs at Zenith Drugs
Salary & Benefits
- Salary: As per company norms
- Estimated Salary Range: ₹5,00,000 to ₹8,00,000 per annum (based on experience and skill set)
Additional Benefits
- Exposure to diverse international regulatory markets
- Long-term career growth in a rapidly expanding pharmaceutical organization
- Stable and professional work environment
- Opportunity to contribute to global product launches and registrations
Selection Process
- Resume screening
- Technical interview (Regulatory Affairs)
- HR discussion and final selection
The process may vary depending on experience level and business requirements.
How to Apply
Interested and eligible candidates should apply through email application by sending their updated resume.
- Email ID: Hrsales@zenithdrugs.com
Candidates are advised to mention the job title in the subject line for faster shortlisting. Regulatory Executive Jobs at Zenith Drugs
Important Dates
- Applications are open until suitable candidates are shortlisted.
Why Apply for This Pharma Job?
This role offers an excellent opportunity for regulatory professionals seeking international exposure and long-term career growth. Working at Zenith Drugs allows candidates to manage global dossiers, interact with multiple regulatory authorities, and be part of a fast-growing organization with strong expansion plans. The position provides stability, learning opportunities, and the chance to strengthen expertise across emerging pharmaceutical markets. Regulatory Executive Jobs at Zenith Drugs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We are not affiliated with Zenith Drugs or any recruitment agency. Job details are shared for informational purposes only. Candidates should verify all information directly with the employer before applying. Regulatory Executive Jobs at Zenith Drugs
Final Call-to-Action
If you have solid experience in international regulatory affairs and are looking to grow with an expanding pharmaceutical company, apply now and take the next step in your regulatory career. Regulatory Executive Jobs at Zenith Drugs
