Junior Regulatory Affairs

Job Title: Jr. Regulatory Affairs (Semi-Regulated Markets)

Company: GenAide Pharmaceutical Pvt Ltd

Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060

About GenAide Pharmaceutical Pvt Ltd:
GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey

Working Days: Monday to Friday (5-day work week)

**Salary**: INR 150000 - INR 300000 per annum

Experience: 01-02 years in Regulatory Affairs, with a strong focus on semi-regulated markets.

Job Summary:
Key Responsibilities:
Regulatory Strategy & Planning: Develop and implement effective regulatory strategies for product registration, lifecycle management, and post-market surveillance in semi-regulated markets.

Dossier Preparation & Submission: Oversee the preparation, compilation, and submission of high-quality regulatory dossiers (e.g., CTD, ACTD, country-specific formats) to health authorities in semi-regulated countries.

Team Leadership & Mentorship: Lead, mentor, and guide a team of regulatory professionals, fostering a collaborative and high-performance environment. Provide technical expertise and support to the team.

Compliance & Due Diligence: Ensure all regulatory activities comply with applicable national and international guidelines, Good Manufacturing Practices (GMP), and company Standard Operating Procedures (SOPs). Conduct regulatory intelligence and assess the impact of new regulations.

Health Authority Liaison: Act as the primary point of contact with regulatory agencies in semi-regulated markets, managing queries, providing responses, and facilitating approvals.

Artwork & Labeling Review: Review and approve product artworks, labeling, and promotional materials for compliance with regulatory requirements.

Post-Approval Variations: Manage and submit post-approval variations, renewals, and other lifecycle management activities for registered products.

Cross-functional Collaboration: Collaborate effectively with internal departments such as R&D, Quality Assurance, Production, Sales, and Marketing to ensure regulatory requirements are integrated into business processes.

Documentation & Record Keeping: Maintain accurate and up-to-date regulatory documentation and databases.

Qualifications:
Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline.

1-2 years of progressive experience in Regulatory Affairs within the pharmaceutical industry, specifically with a strong track record in semi-regulated markets.

In-depth knowledge of regulatory guidelines and requirements for various semi-regulated countries (e.g., ASEAN, LATAM, Africa, CIS regions, etc.).

Proven experience in leading and managing a regulatory team.

Excellent understanding of dossier requirements (e.g., CTD/ACTD structure).

Strong analytical, problem-solving, and decision-making skills.

Exceptional written and verbal communication skills in English.

Ability to work independently and collaboratively in a fast-paced environment.

Proficiency in regulatory

Be a part of a young, dynamic, and rapidly growing company.

Opportunity to lead and shape the regulatory landscape for semi-regulated markets.

Work in a supportive and collaborative team environment.

Enjoy a 5-day work week.

Competitive salary and growth opportunities.

Pay: From ₹18,000.00 per month

**Benefits**:

- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

Application Deadline: 29/08/2025