Senior Director / Vice President, Regulatory Affairs - Obesity and Associated Metabolic Diseases
Location: Charlotteville, VA or Bay Area, CA
Rivus Pharmaceuticals is searching for a Senior Director / Vice President, Regulatory Affairs to set and lead the regulatory strategy to advance a new class of investigational medicines called controlled metabolic accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. This role will report to the CMO. The individual will develop and implement regulatory strategies for all phases of product development, from early product pipeline to post-approval commercial production. They will be responsible for the planning and execution of regulatory filings with in a rapid timeline. They will also provide guidance to cross-functional and matrix team members on regulatory strategy and tactics.
Responsibilities:
Develop and implement the short term and long term regulatory strategies for all development programs, working with the CMO, from pre-IND meetings to pivotal Clinical Trials and through marketing authorization and post-approval submissions.
Represent Regulatory Affairs on Development Leadership Team providing regulatory guidance and assessing the accuracy and appropriateness of submissions to regulatory authorities
Serve as primary author and oversee the development, preparation of documents and management of submissions and interactions with regulatory authorities regarding IND/NDA submissions, scientific advice/briefing materials, CTAs, and responses to regulatory agency questions to support clinical and non-clinical development.
Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
Experience working with FDA, EMA, PDMA and other international regulatory agencies
Perform as a key member on internal and external project teams and serve as the regulatory point of contact to facilitate CMC regulatory development as it relates to global clinical trials, global health authority interactions and global product submissions and approvals
Ensure compliance with all GCP/ ICH and regulatory guidelines
Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.
Provide regulatory strategy support to diligence for potential collaborations as appropriate
Identify and assess regulatory risks associated with product development and define strategies to mitigate risks
Recruits, interviews, and trains new staff as well as manages performance of direct reports and internal contractors , external CROs, and other vendors, as necessary..
Establish relevant processes and procedures to support the Regulatory Affairs function
Provide mentorship and guidance to direct reports in carrying out responsibilities and will be responsible for coordinating activities and career development of direct reports
Develop and maintain departmental procedures, identify opportunities for process improvement,SOP development and propose implementation plans
Qualifications
BS 17+ years, MS 15+ years. PhD 12+ years 10+ years of pharmaceutical industry regulatory affairs experience will include 10 years regulatory experience working on Small Molecule Therapeutics with in Metabolic or Obesity indications.
Previous hands-on experience in interfacing with regulatory authorities and leading regulatory submissions including IND, NDA/sNDA submissions, briefing documents, etc.
Preparation of supportive amendments and supplements (non-clinical, clinical and CMC)
Demonstrated ability to manage multiple assignments, appropriately identify and resolve regulatory issues, and communicate upwards, as needed, to management
Proven successful record of positive FDA interactions required; international global registrations
Experience interacting with external and internal strategic partner on complex regulatory issues.
Ability to work independently and within project teams, etc. to attain group goals
Knowledge of the Code of Federal Regulations and FDA, EMA and ICH guidelines
Experience and knowledge in the preparation of electronic submissions (CTD)
Experience in the oversite of regulatory CMC is a plus
Interested candidates may forward a CV and Cover letter to Careers@rivuspharma.com
About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving
cardiometabolic health by advancing a new class of medicines called controlled metabolic
accelerators (CMAs). Rivus' lead CMA is the investigational small molecule HU6 in development
to treat obesity and associated metabolic diseases, including heart failure with preserved