Freshers Regulatory Affairs Job at Biotech Healthcare for Pharma graduates
Biotech is an organization that provides opportunities for individuals to develop expertise in regulatory affairs, ensuring compliance with country-specific guidelines. We promote diversity and equality, fostering an environment where everyone can contribute to our regulatory success.
Job Title: Trainee Officer – Regulatory Affairs
Location: Ahmedabad, Gujarat, India
Role Objective:
The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing to the organization’s regulatory strategy.
Desired Candidate Profile:
Education: M.Pharm in Regulatory Affairs
Experience: Fresher (0-1 year of experience in regulatory affairs or a related field is preferred)
Skills: Basic understanding of regulatory requirements, strong analytical abilities, attention to detail, and effective communication skills
Attributes: Ability to learn quickly, work in a team environment, and handle multiple tasks efficiently
Role & Responsibilities
Document screening and analysis
- Assist in screening regulatory documents as per registration requirements.
- Verify document requirements against country-specific guidelines.
- Communicate document needs to relevant teams.
Dossier preparation and submission
- Support in preparing, compiling, and reviewing product dossiers.
- Ensure timely submission of dossiers as per project timelines.
- Coordinate with teams for dossier submissions in different markets.
Functional Skills Required
- Basic knowledge of regulatory guidelines and requirements.
- Understanding of document preparation and submission processes.
- Analytical skills for document screening and requirement analysis.
Behavioral Skills Required:
- Strong communication and interpersonal skills.
- High attention to detail and organizational abilities.
- Ability to work independently and collaboratively.
- Capability to manage multiple tasks and meet deadlines.
This role offers a structured learning opportunity for fresh graduates to build a career in regulatory affairs, ensuring compliance and contributing to the regulatory success of the organization.
Keywords: Biotech, Regulatory Affairs, Compliance, Documentation, Dossier Submission, Pharmaceutical Industry, Fresh Graduates. Freshers Regulatory Affairs Job at Biotech Healthcare for Pharma graduates