Are you a fresh M.Pharm graduate looking to kickstart your career in regulatory affairs? Biotech Healthcare, a leading name in the pharmaceutical industry, is hiring for the position of Trainee Officer Regulatory Affairs in Ahmedabad, Gujarat. This is an excellent opportunity for candidates with 0-1 year of experience to gain hands-on experience in regulatory compliance, dossier preparation, and document management. Read on to learn more about this exciting role and how you can apply.
About Biotech Healthcare
Biotech Healthcare is a renowned organization in the pharmaceutical and healthcare sector, known for its commitment to quality and compliance. With a strong focus on innovation and regulatory excellence, the company offers a dynamic work environment where employees can grow and thrive.
Job Title: Trainee Officer Regulatory Affairs
Location: Ahmedabad, Gujarat
Job Type: On-site, Full-time
Experience: Fresher (0-1 year preferred)
Education: M.Pharm in Regulatory Affairs
Key Responsibilities:
As a Trainee Officer Regulatory Affairs, you will play a crucial role in ensuring compliance with country-specific regulatory guidelines. Your responsibilities will include:
- Document Screening and Analysis:
- Assist in screening regulatory documents as per registration requirements.
- Verify document compliance with country-specific guidelines.
- Dossier Preparation and Submission:
- Support the preparation, compilation, and review of product dossiers.
- Ensure timely submission of dossiers in alignment with project timelines.
- Document Legalization and Coordination:
- Assist in the legalization and apostillation of regulatory documents.
- Coordinate with agencies to obtain attested documents.
- Regulatory Query Management:
- Support in reviewing and responding to regulatory queries.
- Prepare compliance-related documentation as required.
- Training and Awareness:
- Participate in training sessions to enhance knowledge of regulatory processes and guidelines.
- Post Market Surveillance (PMS):
- Assist in updating PMS reports for all products.
Desired Candidate Profile:
- Education: M.Pharm in Regulatory Affairs.
- Experience: Fresher or up to 1 year of experience in regulatory affairs.
- Skills: Basic understanding of regulatory guidelines, strong analytical abilities, attention to detail, and effective communication skills.
- Attributes: Quick learner, team player, and ability to manage multiple tasks efficiently.
Functional and Behavioral Skills Required:
- Functional Skills: Knowledge of regulatory guidelines, document preparation, and submission processes.
- Behavioral Skills: Strong communication, organizational abilities, problem-solving mindset, and adaptability to regulatory changes.
