Role - Ensure full compliance with any applicable regulatory and quality requirements of all regulatory bodies related to the import, export, supply and distribution of the products portfolio, for countries in scope. - Act as Regulatory Business Partner to the Commercial Team and provide regulatory strategies and executable regulatory plans that support fast market access and commercial revenue and growth targets. - Be knowledgeable and keep track of the local regulatory requirements and work closely with RA teams within local distributors - Act as a link between the company and regulatory authorities, ensuring that products are imported and distributed in compliance with appropriate legislation. Product Registration/Licensing Management Additional RA/QA operations - Graduate degree in Life Sciences or any related field preferably with post graduate qualification - Minimum of - 7-10 years experience in Regulatory Affairs. Thorough understanding of regulatory requirements for biologics and medical device products industry. - Good understanding and application knowledge of regulatory guidelines and requirement of the countries - Proven track record in writing major regulatory device submissions with strong ability to manage critical projects as part of an interdisciplinary team. - Excellent problem solving and communication skills, must be self motivated and detailed oriented. - Good organizational &amp; time management skills, must be a good communicator with excellent presentation skills, interpersonal/negotiation skills, external orientation &amp; good leadership. - Language Skills: Fluent English - oral and written. - Proficiency in MS Office, Excel and Adobe Acrobat. - Ability &amp; willingness to lead and work in a matrix organization with direct &amp; indirect reporting relationships. - Self-motivated, self-organized, and able to work with minimum supervision. Kalpana Chhatriwala CorporateSearch

Mumbai

Manager - Regulatory Affairs - Pharma 

Manager - Regulatory Affairs - Pharma  ,Job Description for Manager - Regulatory Affairs - Pharma  in Corporate Search in  Mumbai for (7-10) years of experience. Apply Now!

Job Description for Manager - Regulatory Affairs - Pharma  in Corporate Search in  Mumbai for (7-10) years of experience. Apply Now!