Suneeta Sonawane

Head of Regulatory Affairs @Roquette

Mumbai, IN

As part of the Leadership Team, provide regulatory metrics to top management on performance that are aligned with area & global regulatory affairs. Leading regulatory strategies to align with business objectives while ensuring compliance with global and regional regulatory frameworks. Spearheaded sustainability and product lifecycle management, securing regulatory approvals for key product lines in national and international markets. Conducted regulatory training for internal teams, enhancing compliance efficiency across departments. Established and maintained relationships with regulatory authorities, enabling smooth market entry and business expansion. Keep updated with current local regulations and authority organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties. Gain Drug Regulatory Agency’s (DRA) approvals from CDSCO and FSSAI to meet the organization product launch plans and ensure product maintenance. Act on complex labeling issues, coordinating closely with key collaborators to address labeling requirements across local and export markets. Work closely with regional and global Ethics and Compliance, Internal Audit teams in creating and implementing organizational policies, standards, and procedures. Develop Regulatory strategies during Merger and Acquisitions. Monitor compliance to the Quality Management System and QMS-related global regulations for the company’s policies & procedures related to Software Development, Professional Services, Support, and IT organizations Lead/Perform internal quality audits of the organization, including authoring plans and reports, tracking findings and follow up Experience with managing and mentoring teams, training and fostering their professional growth. Global Exposure: Business on-site visits at France, Netherland, and Singapore for training on international regulations.

C.E.H.S, Chembur

High School

Bharati Vidyapeeth's College of Pharmacy, Navi-Mumbai

M.Pharm, Pharmaceutics

Bombay College of Pharmacy, Mumbai

B.Pharm, Pharmacy