Harshal Dhake

Manager Global Regulatory Strategy and Cmc @Indivior

England, GB

Global Regulatory Strategy- Accountable for developing and driving the regulatory strategy for new and existing products including line extensions, new indications and geographical expansion in-line with business objectives- Lead the sub teams to develop strategies which meet the needs of individual markets/regions and represent regulatory on matrix teams within organization- Maintain awareness of evolving regulatory environment and provide risk assessments.Global CMC Regulatory- Accountable for developing, implementing, and advising on global CMC regulatory strategies for all development programs to secure and maintain market access for products- Lead pre and post approval activities and provide regulatory strategy/tactics- CMC management of cross-functional M3 continued compliance projects.Regulatory Compliance- Ensure timely mandatory regulatory compliance activities e.g. valid licenses & product variations for marketed products in EMEA, Canada, USA and international markets that meet local regulations and global policies.Regulatory External Environment- Maintain and enhance positive relationships with regulatory authorities and trade associations, communicating internally the key regulatory trends, requirements, timelines and assessing the impact for new products and compliance activities.Commercial Support- Ensure timely and compliant regulatory activity with respect to artwork, labelling. Reviews and approvals to support commercial team activities. Quality Compliance- Review and approval stability protocols, deviations, risk assessments, validation protocols, master test methods, change control process, regulatory database.Good Regulatory Practices- Work within the defined regulatory and cross functional SOPs to active a compliant robust Regulatory Information Management System.

University of Greenwich

Master of Science (M.S.), Pharmaceutical Sciences

Dr. D.Y Patil Institute of Pharmaceutical Sciences and Research, Pune

Bachelor of Pharmacy (B.Pharm.), Pharmacy