Job Title: Regulatory Affairs – Trainee to AGM
Company: Swiss Parenterals Ltd
Location: Ahmedabad, Gujarat, India
Employment Type: Full-time, On-site
Company Overview:
Swiss Parenterals Ltd is a pharmaceutical manufacturing company based in Ahmedabad, Gujarat, India. With a workforce of 501-1,000 employees, we specialize in the production of pharmaceutical dosage forms. As a subsidiary of a Swiss parent company, we adhere to the highest standards of quality and regulatory compliance in the industry.
Job Description:
We are currently seeking candidates for multiple positions ranging from Regulatory Affairs Executives to Assistant General Managers (AGMs) to join our Regulatory Affairs team. The ideal candidates will possess expertise in regulatory submissions and dossier review for pharmaceutical products, particularly OSD (Oral Solid Dosage) and Parenteral dosage forms.
Responsibilities:
- Conduct thorough review and evaluation of Common Technical Document (CTD), Electronic Common Technical Document (eCTD), and ASEAN Common Technical Document (ACTD) submissions.
- Demonstrate excellent understanding of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), country-specific, and variation guidelines.
- Prepare responses to deficiencies raised by Ministry of Health (MoH) or clients, ensuring accuracy and compliance with regulatory standards.
- Maintain familiarity with country-specific labeling guidelines to ensure compliance during dossier compilation.
- Provide leadership and guidance to team members, effectively delegating tasks and ensuring timely completion of assigned work.
- Review technical documents essential for dossier compilation, ensuring accuracy and completeness.
Qualifications:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm / Bsc / Msc / Lifesciences}
- Experience ranging from 0 to 12 years in regulatory affairs within the pharmaceutical industry.
- Proficiency in CTD/ECTD/ACTD dossier review for OSD and Parenteral dosage forms.
- Strong command of regulatory guidelines and requirements, including ICH and country-specific regulations.
- Ability to prepare comprehensive responses to deficiency queries from regulatory authorities or clients.
- Basic understanding of country-specific labeling guidelines.
- Excellent organizational and leadership skills, with the ability to manage a team and prioritize tasks effectively.
How to Apply:
Interested candidates are encouraged to submit their CVs to hroffice@swiss.in Our office is located in Prahladnagar, Ahmedabad.
Join us at Swiss Parenterals Ltd and become part of a dynamic team dedicated to maintaining the highest standards of regulatory compliance and pharmaceutical quality.