Manager, Regulatory Affairs
Overview
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.
POSITION SUMMARY
This is an outstanding opportunity for you to stand out and make your mark. Kashiv is looking for a dynamic Manager of Regulatory and Clinical Affairs. In this critical role and as part of Kashiv’s management team, you will pro-actively develop, lead and drive the execution of regulatory strategy and systems, as well as develop a submission and clinical trial strategy for US and international countries.
You will support new product development efforts and international expansion, and ensure regulatory compliance associated with submission preparations, regulatory filings, premarket clearances, labeling, reviews, certifications etc.
Responsibilities
Highlights of the role –
• Support all of Kashiv’s Regulatory Affairs, and the development and implementation of regulatory strategies and processes for US and global approval.
• Provide regulatory input to 505(b)2 product life-cycle understanding and planning from product selection stage through R&D and FDA submissions.
• File hard copies and/ or eCTD documents to FDA respective department of CMC and/or Division of Bio-equivalence and Clinical Review or Office of Clinical Pharmacology (OCP)
• Coordinate multiple development projects, and manage the planning, preparation, interpretation and filing of all regulatory documents/submissions with FDA and international regulatory agencies.
• Provide Project Teams with current expertise, knowledge and strategy of applicable FDA and global regulations and requirements. Collaborate and advise the team on resolution of complex project issues.
• Maintain strong internal and external relationships with US and International regulatory agencies and officials, as well as medical/clinical professionals. Monitor applications and assess external communication relative to regulations. Ensure effective clinical projects are in place and completed to support the company product and technology objectives.
• Review ongoing product design and/or manufacturing changes and adverse events. Identify and resolve events that may impact compliance status or pose a significant business risk.
• Support efficient and effective clinical trials including site selection, clinical trial management(study visits, training, monitoring etc.), data analysis, final study reports and publication while ensuring all clinical studies operate to the highest accuracy and completeness in compliance with the highest ethical and safety standards. Monitor competitive regulatory and clinical practices, and actively review internal and external factors to mitigate potential problems.
Requirements:
Qualifications
• Strong knowledge of US agency regulations. Demonstrated ability to develop and execute complex regulatory strategies to expedite products to market, with a focus on efficient, rapid and timely approvals.
• Experience encompassing US FDA and international clinical trial compilation, applications, registrations of new chemical and biological entities, 505(b)(2) products and generics.
• Education equivalent to a BS degree in a scientific field, plus 8 years experience in regulatory affairs; or MS degree or higher in a scientific field, plus 6 years experience in regulatory affairs
• Experience in strategic planning and collaboration with executives and key operational groups. Demonstrated increasing responsibilities and results in a fast paced environment.
• Experience with all phases of the product development life-cycle, as well as cGMP and other Regulatory compliance requirements.
• High level of personal and professional integrity with strong work ethic and ability to work independently with minimal direction. Excellent communication and presentation skills.
• Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.
• Candidate should have the ability to travel domestically and internationally as required.
