While at PharmSci360, you can reach out to Harpreet Sandhu at (631)456-2218.
If you would like to directly speak with our recruiter, Paul Beran, he can be reached at Paulb@kashivpharma.com or (908)895-1539.
Kashiv Pharma, LLC is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture. At the forefront of our dynamic new organization, the Vice President, Regulatory Affairs will be responsible for building and leading a Regulatory Affairs department for the evolving needs of Kashiv. Candidate will be responsible for developing the strategic plan for obtaining approval for products in the pipeline, and for developing strong relationships with the FDA and other global regulatory agencies.
Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets with product labelling that sets a high hurdle for any competitors in the field
Develop effective working relationships with FDA, EMEA, and other regulatory authorities, such as coordinating activities for meetings and leading approval negotiations
Manage the compilation, submission and maintenance of INDs, BLA's and amendments
Build and effectively lead high-performing Regulatory team
Identify gaps in product development plans that may pose regulatory issues and come up with novel endpoint development strategies
Develop and plan innovative regulatory strategies for label enhancements and life cycle product management.
Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications Provide regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates; and
Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA.
Master's Degree in a scientific discipline required. Advanced degree preferred (PhD/PharmD)
15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally and/or globally)
Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record of successful submissions and license approvals
Regulatory experience with biologics and a successful track record leading major applications (such as BLA/MAA) and securing approval
Knowledge, Skills and Other Experience
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance pertaining to drug development and commercialization.
Substantial experience in representing the sponsor and interfacing and negotiating with regulatory authorities (e.g. FDA, EMA)
Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams
Unquestionable ethics, professional integrity and the ability to motivate and lead others
Excellent oral communication and writing skills,
Generates innovative solutions in work situations, trying different and novel ways to address work challenges and opportunities
Proven ability to work in a small company environment where there is a need to play a both strategic and very hands on role
Travel: Up to 25% of the time, including international travel
About Kashiv Pharma
The company’s mission is to develop the next generation drug delivery platforms, and apply these proprietary technologies to create a portfolio of improved versions of known medicines with meaningful clinical differentiation and a compelling value proposition for patients, physicians, and payers. Kashiv intends to utilize the accelerated regulatory approval process to bring these improved drugs to market faster and more efficiently.
Kashiv aspires to become a world-class premier drug delivery, development, and specialty pharmaceutical company with a portfolio of improved medicines through the use of cutting-edge innovation, proprietary platform technologies, and strategic partnerships throughout the industry.