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Contact

Manager – Regulatory Affairs

Country Location Company Date
India, IN Thane (W) - 400 604, Maharashtra LANXESS India Pvt. Ltd. 2016-10-20

Business Unit: Material Protection Products

Reports to: Head - South Asia, MPP

Qualification: MSC / B.Tech / B.E,  Masters in Agriculture / Chemistry, Food, Pharma, PhD is preferred not mandatory with more than 10 years of experience

Job Responsibilities:

The following duties are not intended to serve as a comprehensive list of all duties performed by the employee. Listed are duties intended to provide a representative summary of the major duties and responsibilities. The employee may be required to perform additional, position-specific duties.

• She/he is required to discuss critical RA topics with authorities, advocacy groups and customers not only in India, but in the Region and adequately represent LXS
• Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to product registrations / approvals, as required by procedures relating to the regulatory requirements
• Compilation of Registration data for submission at competent registration authorities in SEASAME (South East Asia and Middle East) Region
• Establish and maintain close relationships with appropriate regulatory agencies for the purpose of effective negotiations of registration requirements, determine status and facilitate approvals of products submitted for registration
• Supply testing and compliance requirements for new or modified products as required by registration authorities
• Liaison with scientists of Agricultural Universities, GLP Test Facilities and other accredited agencies for country specific field trials
• Attend international seminars / talks pertaining to product registration matters
• Remain abreast of changes in global testing requirements, both implemented and proposed, send samples, coordinate and ensure follow through with GLP / FDA / EPA
• She/he should take ownership for SEASAME - RA projects, leading/advising internal (MPP, PTSE) and external (consultants, laboratories) RA resources available in the region

Other requisites:

• Experience in handling Regulatory Affairs in atleast two countries outside of India in the context of chemical/pesticide/Drug/Pharma registrations