Cambridge, Massachusetts, United States
I have overall work experience of over 25 years in the areas of Drug Regulatory affairs, Strategic Affairs and Project Management in the Pharmaceutical and Biological industry at management level. GLOBAL REGULATORY KNOWLEDGE: After working many years in Regulatory Affairs CMC, I have gained profound knowledge of biological products, small molecule products(solid and liquid dose) and generic products development/approval and post approval requirements in Canada, US, Europe and JAPAC region. AREAS MANAGED: During these years I have been engaged in creating and managing a successful affiliate regulatory affairs team and building strong relationship with regulatory agencies. Other areas of focus include exploring and benchmarking the options for successful outsourcing of regulatory functions, spearheading the pursuit to identify opportunities for early launch of generic pharmaceuticals in the Canadian market. I also have developed successful models to track, strategies and leverage opportunities for early market entry of generic pharmaceuticals. I have worked closely with the Senior Management to develop company strategy from regulatory perspective. Besides interfacing with the cross functional teams across the organization, I have been an active member of various cross functional teams working on various companywide initiatives. SPECIALTIES: My versatile, forthright collaborative management style has facilitated a successful career delivering strategic projects and processes in global matrix team environment. I am a result-driven and knowledgeable individual, who lead and deliver the projects while building and maintaining relationships with stakeholders, colleagues and direct reports. High level of personal integrity and interpersonal skills.
Led global CMC regulatory strategy and submissions for multiple assets across all lifecycle stages. Managed preparation, review, and approval of global CMC submissions and responses, ensuring alignment with ICH and local regulations. Identified and communicated regulatory risks to cross-functional and leadership teams. Directed cross-functional teams for submission preparation and agency interactions, including briefing books and presentations. Managed relationships with partners, CMOs, and CTOs to support business objectives. Supported GMP inspections and company quality initiatives. Drove process transformation initiatives to reduce cycle times and enhance submission excellence. Led compliance gap assessments and develop scientific justifications for regulatory issues. Led and Managed Regulatory Information Management (RIM) System through Veeva platform rollout. Mentored, Managed and developed direct reports and junior regulatory team members.
Managed a team of regional product leads, contactors and associates responsible for global Reg. CMC activities for the commercial products. Led and advised on regulatory strategy and review of regulatory filings for post-approval variations. Represented Global Reg. CMC department on cross-functional project teams and select X-functional initiatives. was responsible for developing processes and tools for effective compilation of global post-approval supplements. was responsible for leading cross functional teams to drive continuous improvements projects across functions. Analyzed and adapted regulatory strategies for post-approval trends. Analyzed and commented on due diligence activities from regulatory CMC function. was responsible for developing highly efficient and adaptable teams.
Global Regulatory Lead: was a GRA-CMC lead for commercial biologic programs. Member of global regulatory and global operations teams responsible for developing global regulatory strategy for post approval CMC changes including manufacturing process changes, changes to control strategy, second source syringe supplier and design improvements to the device. Led the development, communication, and implementation of global regulatory strategies in support of team goals and product portfolio execution. Represented Global Regulatory Affairs on cross-functional development teams. Provided regulatory risk assessment to the respective functional teams. Led development and execution of global product development strategies, including regulatory review of chemistry, manufacturing, controls and related regulatory documents required to support product development and registration. Led development and maintenance of high quality regulatory documents (CTAs/INDs, Marketing Applications, Post-Approval variations, Annual Reports and Responses to Health Authority questions) with the focus on CMC aspects. Collaborated and effectively communicated with partners and affiliates as required to ensure implementation of global regulatory strategies.
Site CMC Lead: was responsible for regulatory activities at multiple commercial DS & DP manufacturing sites including, change control regulatory support for NCs, CAPAs, risk assessments, and new product introductions (NPIs). Led site-specific regulatory submissions for Tech. Transfers, Method Transfers etc. Led template development for registration of a new site for QC/Stability testing (method transfer) variation to increase efficiency, consistency and automation across all the programs. Developed and executed global regulatory strategies for submission and implementation in support of team goals and product portfolio execution from CMC side. Supported planning and execution of Health Agency meetings, Regulatory and GMP inspections including generation and submission of briefing books, meeting and inspection preparations. Represented Global Regulatory Affairs on cross-functional development teams. Provided regulatory risk assessment to the respective functional teams. Supported development and maintenance of high quality regulatory documents with the focus on CMC aspects. Served as the Business Process Owner (BPO) for Change Controls from RA CMC side. Supported the business, functional area training and change control network for the change controls from regulatory side. Served as the Annual Report Coordinator, coordinating efforts for commercial products, streamlining the process to reduce redundancies and drafting of manuals. Served as the NC and CAPA Owner – Created and managed investigations, NCs and CAPAs within RA teams to support the business priorities and continuity.