Regulatory Affairs Executive Fresher Job

Job Description:
We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team. This role is integral to ensuring compliance with regulatory requirements and supporting the successful approval and lifecycle management of our products. The ideal candidate will have a strong foundation in biotechnology and a keen interest in regulatory processes.

Key Responsibilities:

1. Prepare, review, and submit regulatory documents, dossiers, and applications in compliance with local and international regulatory requirements.
2. Coordinate with internal teams to gather necessary data and documentation for regulatory submissions.
3. Monitor and ensure compliance with applicable regulatory guidelines, standards, and legislation.
4. Communicate with regulatory authorities to address queries and facilitate approvals.
5. Maintain accurate records of regulatory submissions, approvals, and ongoing compliance activities.
6. Stay updated on changes in regulatory policies and guidelines relevant to the biotechnology sector.
7. Provide support in audits and inspections by regulatory bodies.

Qualifications:

1. Bachelor's or master's degree in biotechnology or a related field.
2. 0-2 years of experience in regulatory affairs or a similar role.
3. Basic knowledge of regulatory guidelines and standards (e.g., FDA, EMA, CDSCO).
4. Strong analytical and problem-solving skills.

Preferred Qualifications:
* Exposure to regulatory processes in the biotechnology or pharmaceutical industry.
* Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
* Effective communication and documentation skills.

Skills:
1. Excellent organizational and time management skills.
2. Attention to detail and a commitment to accuracy.
3. Proficiency in MS Office applications.
4. Ability to work independently and collaboratively in a team environment.

Personal Attributes:
1. Self-motivated and proactive in learning new regulatory requirements.
2. Strong interpersonal skills with the ability to build effective relationships across teams.
3. Flexible and adaptable to changing priorities and deadlines.

1