Job Title: Regulatory In-charge (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! Job Type: Full-time Working Days: Monday to Friday (5-day work week) Salary: INR 5,00,000 - INR 8,00,000 per annum Experience: 5 - 8 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seeking an experienced and highly motivated Regulatory In-charge to lead our regulatory team for semi-regulated markets. The ideal candidate will be responsible for overseeing all regulatory activities, ensuring compliance with local and international regulations, and facilitating timely product registrations in these key regions. This leadership role requires a proactive approach, excellent communication skills, and a deep understanding of regulatory pathways in diverse semi-regulated environments. 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. 5 to 8 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 databases and software is a plus. Why Join GenAide Pharmaceutical Pvt Ltd? 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.