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.
The Manager, Clinical Regulatory provides support for the development of biologics and biosimilar products while managing the entire lifecycle of the product ranging from the development of clinical strategy, execution, submission to the regulatory agencies, and following through the approval process. The individual will support existing products as well as provide regulatory support for new products in the portfolio.
Participates in establishing regulatory strategy to support investigational products.
Researches, reviews, and interprets related product approvals, current regulatory guidance including Advisory Committee proceedings, to support the development of optimal regulatory strategies
Interacts with internal and external collaborators and consultants for various regulatory matters as needed
Coordinates interactions with regulatory agencies including milestone meetings, controlled correspondence, and regulatory submissions
Plans and coordinates regulatory submissions and activities, including pre-IND and other meetings with FDA and European Regulatory Agencies, INDs, CTAs, Annual Reports/DSUR, IND/CTA amendments; assures completeness and quality of submissions; identifies issues, suggests and implements solutions
Provides regulatory support for clinical operations, manufacturing, and non-clinical studies
Acts as the Regulatory representative on specific project teams
Conducts regulatory review of clinical documents, including: protocols, informed consent, and clinical study reports
Provides the regulatory review of non-clinical documents, including: toxicology protocols and reports, pharmacology reports, pharmacokinetic and toxicokinetic reports
Assist in the regulatory review of CMC requirements including: characterization methods, specifications, stability protocols, and batch records.
Oversees preparation, review and publishing of final submissions to meet regulatory requirements; develops or revises regulatory templates, processes and procedures to ensure compliance with regulations
Asist the clinical CRO capabilities with respect to protocol requirments
Engage with health-authorities to manage the Pre-approval inspection.
Guide the regulatory activities to comply with the post-approval requirements
Ensures submission to the appropriate regulatory authorities.
Complies with all applicable policies regarding health, safety, and environmental policies
Performs other functions as required or assigned
Complies with all company policies and standards
Advanced degree in life sciences or a relevant discipline with at least 5 years’ experience in a regulatory affairs function in a biopharmaceutical company; or equivalent.
Must have in-depth knowledge of regulatory requirements and guidances, including FDA regulations, ICH and EMA guidelines/directives
Experience with the regulatory submissions process, including electronic submissions and CTD format
Strong analytical and problem solving skills
Ability to coordinate and work effectively with cross-functional teams
Must demonstrate excellent communication skills, including writing, verbal and interpersonal skills
Detail oriented. Strong organizational and time management skills; ability to adhere to timelines
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project
Demonstrated ability to quickly adapt and learn new systems
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.