Are you passionate about pharmaceutical regulatory affairs and ensuring compliance in global markets? Uniza, a dynamic division of Pashupati Group, is hiring a skilled Regulatory Affairs Executive to handle the preparation and compilation of ACTD, CTD, and country-specific dossiers for products targeting Rest of World (ROW) markets. This role is perfect for professionals with 2+ years of experience in pharma regulatory affairs jobs, offering a chance to contribute to innovative pharmaceutical solutions. Located in Ahmedabad, Gujarat, Uniza is expanding its footprint in international pharmaceutical markets, making this an exciting opportunity for regulatory affairs executives in India.
Key Responsibilities
- Prepare and compile comprehensive ACTD (ASEAN Common Technical Dossier) and CTD (Common Technical Dossier) formats for pharmaceutical product submissions.
- Develop country-specific regulatory dossiers tailored for ROW markets, ensuring adherence to international standards.
- Collaborate with cross-functional teams to gather necessary documentation for successful regulatory filings.
- Stay updated on global regulatory guidelines and support the expansion of Uniza’s product portfolio in emerging markets.
- Assist in regulatory compliance audits and documentation for pharmaceutical exports.
These responsibilities highlight the critical role of a regulatory affairs executive in driving pharma regulatory affairs strategies for international growth.
Qualifications and Experience
- Bachelor’s degree in Pharmacy (B.Pharm) or Master’s degree in Pharmacy (M.Pharm).
- Minimum 2+ years of hands-on experience in regulatory affairs within the pharmaceutical industry, preferably with dossier preparation for ROW markets.
- Strong knowledge of ACTD, CTD, and country-specific regulatory requirements.
- Excellent attention to detail, analytical skills, and proficiency in regulatory documentation tools.
- Familiarity with pharma regulatory jobs in India and global compliance standards is a plus.
Candidates with experience in pharmaceutical regulatory affairs jobs will thrive in this position at Uniza.
Benefits
As part of the Pashupati Group, Uniza offers competitive benefits including:
- Attractive salary range of INR 4.5 – 7.5 Lakhs per annum, based on experience.
- Opportunities for professional growth in a rapidly expanding pharmaceutical company.
- Health insurance, paid time off, and performance-based incentives.
- Collaborative work environment focused on innovation in pharma regulatory affairs.
How to Apply
Interested candidates should send their updated resume and cover letter detailing relevant experience in regulatory affairs executive roles to hr_corporate@unizagroup.com. Mention “Regulatory Affairs Executive Application” in the subject line. Applications are reviewed on a rolling basis—apply today to join Uniza’s team!
FAQs
- What experience is required for the Regulatory Affairs Executive position at Uniza? A minimum of 2+ years in pharmaceutical regulatory affairs, with expertise in ACTD/CTD dossier preparation for ROW markets.
- Where is Uniza located, and what is the salary range for this pharma regulatory job? Uniza is based in Ahmedabad, Gujarat, India. The realistic salary range is INR 4.5 – 7.5 Lakhs per annum for candidates with the required qualifications and experience.
