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 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.
Actively contribute to the development and implementation of regulatory strategies, processes and timelines 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 ensuring that overall regulatory strategy aligns with the target product profile (TPP).
Manage interactions with other functions (e.g., Quality, Operation and Compliance) to ensure compliance with regulatory requirements for day-to-day operation and Quality Audits (Internal or Regulatory Authority).
Monitor competitive regulatory and clinical practices, and actively review internal and external factors to mitigate potential problems.
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. Assist with Pharmacovigilance compliance and support for US reporting requirements. Provide global and US regulatory labeling expertise to teams
Ensure that draft labeling complies with all applicable regulations and guidelines
Work with cross-functional teams to ensure that desired label statements will be adequately supported by submission documents
Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance.
Responsible for all aspects of regulatory submissions, including IND, BLA, ANDA, NDA and major Supplements in electronic format per the eCTD requirements.
May manage assigned personnel
Occasional travel will be required
Demonstrated ability in analytical reasoning and critical thinking skills
Strong capability to contribute in a team environment
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
Excellent communication skills; both oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Demonstrated ability to contribute to a continuous learning and process improvement environment
Capacity to react quickly and decisively in unexpected situations
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
Focused ability to influence operational excellence and performance metrics
Risk adverse where needed with the ability to identify potential solutions to complex problems
Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
Demonstrated experience with health authority submissions, i.e., authored, reviewed and managed an original/supplemental application (IND, NDA, ANDA, MAA, CTA, NDS, etc.
Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
Ability to influence and partner with cross-functional teams in a pharmaceutical organization
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
8+ years relevant pharmaceutical industry and regulatory experience
Bachelor’s degree in science or health related field. Advanced degree preferred.