Principal Consultant at Astitva HR Solutions Private Limited
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Lead - Regulatory Affairs (5-8 yrs)
Role
- Keeping track of the ever-changing legislation in all the Indian and International regions in which the company wishes to distribute its products. (Primarily US, Europe, India)
- Advising on legal and scientific restraints and requirements
- Collecting, collating, and evaluating scientific data
- Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
- Giving strategic and technical advice at the highest level in the company, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole
- Conscious tracking of any gaps and errors in documentation and continuous updating as necessary.
- Aligning the efforts of the plant team as per regulatory norms.
- Regular audits and creating a structured review mechanism
QUALIFICATIONS AND EXPERIENCE REQUIRED :
- Graduate in any field, preferably in Biotechnology or life sciences.
- 5-10 years of experience in managing regulatory affairs for a biomedical device company.
- Hands-on experience in creating and filing dossier for USFDA, Notified CE and thorough understanding of ISO 13485 documentation and implementation.
- Experience in dealing with regulatory bodies and factory-based teams.
