ASolution Pharmaceuticals Pvt. Ltd., a prominent name in the pharmaceutical and chemical industry, is currently hiring Regulatory Affairs Officers, Senior Officers, and Executives to join their Ambernath, Thane facility. This opportunity is ideal for professionals with 3 to 10 years of experience specializing in Regulatory Affairs within the Chemical, Intermediate, and API (Active Pharmaceutical Ingredient) sectors.
About ASolution Pharmaceuticals Pvt. Ltd.
ASolution Pharmaceuticals is recognized for its excellence in manufacturing APIs and pharmaceutical intermediates, with a strong focus on regulatory compliance and global business expansion. The company boasts a robust team skilled in navigating the complex regulatory landscape and ensuring that their products meet global standards. ASolution is also the force behind PharmaBharat.com, a dedicated platform that connects job seekers with the pharmaceutical industry’s latest openings and news.
Job Location and Work Environment
- Location: Ambernath, Thane, Maharashtra (On-site)
- Work Environment: Dynamic, professional, and compliance-driven
- Immediate joiners preferred for fast-paced project needs
Key Responsibilities
- Regulatory Documentation: Prepare, review, and submit regulatory documents for drug approvals at both domestic and international levels.
- Compliance Assurance: Ensure strict adherence to regulatory standards set by agencies like CDSCO (Central Drugs Standard Control Organization), USFDA (United States Food and Drug Administration), EMA (European Medicines Agency), and others worldwide.
- Cross-Functional Coordination: Work closely with teams from different departments to streamline regulatory submissions and approvals.
- Regulation Monitoring: Stay up-to-date with changes in pharmaceutical regulations and ensure company processes are aligned accordingly.
- Clinical Trial Support: Assist in preparing documentation for clinical trials and support regulatory audits to maintain compliance.
Required Skills and Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Science, or related fields (B.Pharm, M.Pharm, MSc, M.Tech)
- 3 to 10 years of hands-on experience in Regulatory Affairs, particularly in the Chemical, Intermediate, and API industries
- Strong understanding of pharmaceutical compliance and clinical trial regulations
- Experience with CTD (Common Technical Document) and eCTD (electronic CTD) submissions
- Excellent communication skills and attention to detail for preparing and reviewing documentation
- Ability to coordinate with multiple teams and manage regulatory processes efficiently
Why Work at ASolution Pharmaceuticals?
ASolution Pharmaceuticals offers a vibrant and professional workplace where regulatory experts can grow their careers. The company is committed to innovation and compliance, providing employees with:
- Opportunities to work on cutting-edge pharmaceutical products
- Exposure to international regulatory standards and procedures
- A collaborative work environment with experienced professionals
- Competitive salary packages and benefits
- Scope for continuous learning and professional development
How to Apply
Interested candidates with the relevant experience and skills are encouraged to apply by sending their updated resumes via email to the HR department at ASolution Pharmaceuticals. Immediate joiners are preferred, making this a great opportunity for professionals ready to advance their careers in regulatory affairs.
Final Thoughts
Regulatory Affairs is a critical function within the pharmaceutical industry, ensuring that products comply with legal standards and reach patients safely and efficiently. The opening at ASolution Pharmaceuticals offers a promising career path for experienced professionals eager to work in a challenging and rewarding environment. If you meet the qualifications and are ready to take on this role, don’t hesitate to apply and join a leading pharmaceutical company committed to excellence.
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