Vice President/Senior Vice President, Regulatory Affairs
Vice President/Senior Vice President, Regulatory Affairs
Vice President/Senior Vice President, Regulatory Affairs, will be responsible for all aspects of the Regulatory function. This person will prepare Regulatory development strategies, advise management on Regulatory risk and lead interactions with Regulatory agencies on behalf of the company. S/he will be responsible for leading regulatory efforts through the lifecycle of IND/NDA submissions, commercial regulatory management, product pipeline development strategy and evaluating potential therapeutic targets. This position involves both high level strategic planning as well as hands-on responsibilities to support the growing pipeline. This position will report to the SVP, Operations.
- Regulatory Leadership
- Develop US and global regulatory strategy aligned with business objectives
- Provide guidance, direction and leadership on strategy to the development team, senior management and Board of Directors
- Make strategic contributions to clinical development plans
- Maintain up-to-date knowledge of US laws, regulations and guidelines as well as familiarity with the global regulatory environment
- Act as primary liaison with all regulatory authorities via regulatory correspondence and leading regulatory meetings
- Identify and coordinate with regulatory experts and consultants
- Ensure operations in are compliant with FDA, ICH, EMA and industry standards
- Commercial Operations Support
- Prepare, submit and maintain regulatory files (NDAs, supplemental NDAs, etc.) for approved products
- Interact with regulatory agencies to facilitate approval for product, manufacturing, and labeling changes
- Review marketing promotional materials and provide leadership/guidance in the development of compliant sales training, advertising and detail literature
- Advise Medical Liaison and Medical Communications groups regarding regulatory issues and impacts of these activities
- 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
- Regulatory Submissions
- Author, review and edit regulatory submissions
- Provide project plans and timelines for regulatory submissions
- Drive timelines and deliverables related to submission documents
- Ensure QC checks of pending submissions
- Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions
- Regulatory Documentation
- Author, review and/or edit documents i.e., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports as necessary
- Senior Management Team
- Chair with Senior Management Committee
- Participate and provide strategic advice on regulatory, clinical, finance, commercial decisions for Company
- Present at quarterly Board of Directors meetings and participate in financial roadshows and Business Development discussions
Qualifications and Experience:
- Advanced degree with minimum of 15 years of industry, 8 – 10 years of direct regulatory experience and 5 years’ experience in a senior regulatory role
- Drug/device combination experience
- Successful NDA and/or Drug combination product filing and approval is highly desired
- Excellent working knowledge of drug and device development process and knowledge of FDA and EU regulatory requirements
- Substantial experience in all aspects of regulatory affairs, including successful IND/NDA submissions, Commercial support, CMC, Clinical, Device; experience with combination product submissions a plus
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
- A demonstrated ability to manage regulatory activities and deliver against program timelines and be comfortable in a flexible working environment that will include working independently as well as a team environment
- Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
- Ability to provide strong regulatory leadership on a cross-functional team
- Strong strategic and analytical abilities
- Electronic submission experience (desired but not a requirement.)
- Excellent organizational, interpersonal, communication and negotiation skills
- CMC regulatory leadership and strategy experience a plus
Skills and Abilities
- Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
- Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
- Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
- Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
- Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
- Empowered Communication: You possess and demonstrate strong communication and interpersonal skills.
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.