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Lead Regulatory Affairs_ Chandigarh, HP and Parwanoo

5.00 to 10.00 Years   Chandigarh   01 Aug, 2022
Apex Services
Job LocationChandigarh
EducationNot Mentioned
SalaryNot Disclosed
IndustryBPO / Call Center
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Roles and ResponsibilitiesKeeping 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 mechanismDesired Candidate ProfileQUALIFICATIONS 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 Perks and Benefits,

Keyskills :
regulatory affairsiso 13485legislative relations

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