Commercial Regulatory Affairs Associate Director/Director
With FDA approval of our FUROSCIX® NDA anticipated this year, we are seeking an Associate Director or Director of Regulatory Affairs who will serve as the Regulatory Lead on relevant projects and represent scPharmaceuticals as the regulatory contact with relevant divisions of FDA, specifically the Office of Prescription Drug Promotion (OPDP). In addition, this position will ensure compliance with CGMP manufacturing regulations, be responsible for adverse event and medical device oversight and reporting and maintain post-approval regulatory applications/files. This team member will engage cross functionally to interact with commercial, medical, legal, quality, product development and relevant vendors on a regular basis and would require occasional travel. This position reports to the VP of Regulatory Affairs. We offer a wonderful company culture, competitive compensation, equity, and great employee benefits. Now is an exciting time to join this rapidly growing organization and bring new products to patients!
- Post approval product changes and GMP
- Review drug and device change control documents and assess for appropriate reporting; ensure timely submission of all drug and device related change documents to FDA.
- Participate in the Change Control Review Board to review product changes for regulatory impact.
- Work with VP of Regulatory Affairs to determine and execute appropriate reporting to FDA
- Manage the annual reporting process.
- Provide oversight and direction for comprehensive drug safety program and pharmacovigilance activities to support commercialization and clinical development.
- Liaise with various stakeholders (e.g., medical, quality, business partners) to establish and maintain a robust PV and risk management program that evolves as scPharmaceuticals grows.
- Lead signal detection/safety surveillance activities and risk-management activities, including development of safety management plans, individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments to the appropriate stakeholders.
- Ensure appropriate adverse event data collection, processing, and reporting for compliance with relevant international requirements.
- Provide expertise and approve relevant sections of clinical and regulatory documents (e.g., protocol, informed consent, study report, product labeling, aggregate safety reports).
- Establish appropriate pharmacovigilance policies and procedures, as well as compliance metrics generation and review, to ensure PV inspection readiness at all times.
- Manage and oversee vendors and external consulting services for conducting PV-related activities.
- Maintain knowledge of pharmacovigilance requirements and industry best practices.
- Provide regulatory strategic oversight to ensure regulatory compliance of promotional materials generated for Marketed products in the US
- Review for consistency with regulations and company policies US promotional materials, disease awareness communications, field medical materials, sales training materials, and corporate communications.
- Attend the Medical/Legal/Regulatory review committee (MLRC) and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with company policies and FDA regulations.
- In collaboration with the VP of Regulatory, serve as the contact for communications with the OPDP for assigned products.
- Provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the company pipeline.
- Participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials.
- Ensure timely submission of all applicable regulatory reporting for post-marketing activities.
- Assist Regulatory Affairs department with IND and NDA submissions for new products as necessary
- Help develop best practices to establish standards and consistency across company products, including ensuring regulatory policies comply with FDA requirements.
- Participate in professional associations and training meetings related to advertising and promotion regulatory requirements and relevant medical congresses within assigned therapeutic areas.
- At least five years in pharmaceutical or biotech industry with at least three years in post-marketing regulatory affairs
- MS in Regulatory Affairs. Bachelor’s degree in a scientific discipline and advanced degree (MS, PhD, PharmD) preferred
- Solid knowledge of U.S. FDA regulations and guidance pertaining to post-marketing compliance and reporting for drug product and device
- Direct recent experience communicating and negotiating with OPDP
- Direct recent experience leading post-marketing compliance and reporting activities at a small company
- Strong listening, verbal, and written communication and presentation skills
- Knowledgeable on industry compliance requirements and enforcement trends
- Digital review experience desired
- Experience with eCTD submissions and Veeva Vault PromoMats a plus
Skills and Abilities
- Strong interpersonal and communication skills
- Ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines
- Self-directed and able to work at all levels of the organization with a “hands on” management style to accomplish goals
- Thriving in small company environments and know how to maximize use of internal and external resources; understand, appreciate, and desire to work in a growing organization
- Entrepreneurial mindset and approach to business challenges
- Acting with impeccable integrity and treat your colleagues and business partners with the utmost respect
- Understanding strategy, transition to execution, and effectively lead teams and/or peers through this process
- Striving for excellence and expecting the same from team and colleagues
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.