Apprentice Openings: Regulatory Affairs and Pharmacovigilance (2025)
Unichem Laboratories Limited is seeking motivated and enthusiastic individuals to join our team as Apprentices in Regulatory Affairs and Pharmacovigilance at our Kandivali (Mumbai) facility. This is an outstanding opportunity for recent graduates with a background in pharmacy, chemistry, biotechnology, or related life sciences to gain hands-on experience in the pharmaceutical industry. As an Apprentice, you will receive valuable training and mentorship from experienced professionals, laying a solid foundation for a successful career in Regulatory Affairs or Pharmacovigilance.
Job Summary:
This apprenticeship program is designed to provide practical experience and training in either Regulatory Affairs or Pharmacovigilance. Apprentices will assist in various tasks related to regulatory submissions, drug safety monitoring, and compliance. This is a full-time, entry-level position based in Kandivali East, Mumbai.
Responsibilities:
Responsibilities will vary depending on the chosen specialization (Regulatory Affairs or Pharmacovigilance):
Regulatory Affairs Apprentice:
- Assist in the preparation and submission of regulatory dossiers (CTD/ACTD) for domestic and international markets.
- Support regulatory compliance activities, ensuring adherence to relevant guidelines and regulations.
- Collaborate with cross-functional teams to ensure accurate and compliant artwork and labeling for pharmaceutical products.
- Maintain regulatory databases and track the progress of submissions.
- Assist in the compilation and organization of regulatory documentation.
Pharmacovigilance Apprentice:
- Participate in case processing of adverse drug reactions (ICSRs), including data entry, assessment, and reporting.
- Conduct literature screening to identify relevant safety information.
- Assist in the management of safety data, ensuring accuracy and completeness.
- Support MedDRA coding and narrative writing for adverse event reports.
- Contribute to signal detection and risk management activities.
Requirements:
- Education:
- M.Pharm (Pharmaceutics, Pharmacology, Regulatory Affairs preferred)
- B.Pharm
- M.Sc (Chemistry, Biotechnology, Microbiology, Life Sciences)
- B.Sc (Chemistry, Biotechnology, Microbiology)
- Experience: Freshers or candidates with up to 1 year of relevant experience.
- Skills:
- Strong communication and interpersonal skills.
- Excellent analytical and problem-solving abilities.
- Attention to detail and a commitment to accuracy.
- Basic computer proficiency.
Benefits:
- Competitive stipend during the apprenticeship period, aligned with industry standards.
- Comprehensive training and mentorship provided by senior professionals in the field.
- Opportunity for potential absorption into a full-time role based on performance and company needs.
- Exposure to cutting-edge pharmaceutical processes and technologies.
- Work in a USFDA-approved, research-driven environment.
Job Location:
Kandivali East, Mumbai, Maharashtra
How to Apply:
Interested candidates are encouraged to submit their updated resume to [email protected].
Please include either “Application for Apprentice – Regulatory Affairs” or “Application for Apprentice – Pharmacovigilance” in the subject line of your email to ensure proper routing.
For any inquiries, please contact us at +91 (22) 66474210 / 4213.
We look forward to receiving your application!