Lead/Head Regulatory – DTX

AREAS OF RESPONSIBILITY (AOR)

Dtx Regulatory Strategy

• Enable and oversees the development and drives execution of effective & progressive digital product regulatory strategies for early development projects, within clinical studies, andthrough the transition to mature commercial products 
• Creates and continuously develops a best-in-class regulatory digital team by providing deeper insights, strengths, and skills complementing the team’s regulatory expertise andestablishing the optimal team operating model that improves Dtx regulatory role supportingdigital product innovation 
• The Dtx regulatory leader is a key representative for interactions with regulatory agencies by defining regulatory expectations for teams, positions response for regulatory agencies, andassures successful negotiations of strategies and execution 
• Effectively lead the substantive, operational and administrative aspects of the Dtx project tomaximize business opportunity 
• Lead the regulatory digital health team for all regulatory activities associated with the registration and maintenance of new and approved digital/medical device products across thray areas 
• Lead regulatory digital health team to offer advice, consultations, and training to internal and external stakeholders on current global state of digital health technologies, regulations and guidelines 
• Keep abreast of evolving digital state-of-the-art data or information science, tools and technology, global regulations, and best practices to be able to assist with identifying andevaluating solutions that enhance drug development programs 
• Responsible for team’s staffing, organizational structure and functional, and task distribution management decisions 
• Accountable for ensuring consistently delivering high quality strategic decisions, direction, and advice commensurate with business requirements and priorities. Develops regulatory strategic objectives, goals, and performance measures 
• Direct and oversee the preparation, accuracy, messaging, and completeness of regulatorysubmissions that support business portfolio

Cross Functional Collaboration and Decision Making

• Support external meetings on regulatory matters, including with regulators and auditors, development partners, and scientific and clinical advisors 
• Maintain records of correspondence with regulatory agencies 
• Develop and implement policies, processes, and SOPs in support of the regulatory affairs function. Participate in strategic product development meetings, providing regulatory direction, strategies and timelines 
• Perform regulatory intelligence including monitoring changing global regulatory requirements. Assist in reviewing, assessing impact, and informing management

Knowledge:

Pharmaceutical Industry Market Knowledge, Digital therapeutics, Regulatory approval process, Competitive landscape, Conceptual understanding of the Product development process in R&D (Concept to commercialization); Thorough knowledge of medical device design control and risk management processes and regulations, including software as a medical device; Knowledge of clinical and data requirements in support of regulatory filings Advanced MS office skills (MS Excel and MS PowerPoint)

Business Understanding:

An overall understanding of pharmaceutical business processes such as Product Development, Regulatory requirements; Experienced in submitting applications and approval requests with international regulatory bodies; Developed regulatory strategies for U.S. and international markets

Education & Experience:

MBBS / Ph.D. / MBA / M Pharm / Social Science Master degree with 5+ years in regulatory affairs in a regulated industry; pharma, life sciences technology, digital therapeutics, med devices. 

Miscellaneous:

• Mentor /guide the youngsters/interns in the team 
• Personal Development and Ad hocs Learnings; Provide any support required by the team as and when required