Clinical Regulatory Affairs Director (Remote)

At Facet, our mission is to make life sciences dreams a reality.  We are regulatory and development leaders with a passion for designing and leading the implementation of innovative strategies and tactical solutions to advance great science.  Our experience enables us to deliver streamlined and innovative solutions for small organizations to help expedite products to and through FDA to patients in need.

For over 10 years, Facet has leveraged our strong scientific and regulatory expertise to help small organizations reach successful outcomes in the US, from product concept to commercialization.  We love to tell a good story and great science makes for a great story!

If you thrive in an environment where you lead the clinical regulatory strategy and tactical activities for small organizations developing groundbreaking products for the US market, Facet may be the perfect place to satiate your scientific curiosity, showcase your creativity, and achieve your career aspirations.  Come help us create great success stories – both for our customers and for you!

Role description:

The Clinical Regulatory Affairs Director (Strategic Program Champion) is focused on helping organizations advance their drug, biologic, device, and combination product through regulated development in the US.  This involves the strategic formulation and execution of aggressive regulatory plans designed to achieve clinical and regulatory milestones with FDA under tight timelines and budget constraints.

To be successful, the Clinical Regulatory Affairs Director formulates, leads, and implements innovative clinical regulatory strategies based on client input (stated goals, corporate objectives, and risk tolerance), experience with the regulatory environment and US FDA, and through strong teamwork with Facet colleagues and partners.  The Clinical Regulatory Affairs Director is accountable for direct interactions with FDA and timely submissions to health authorities.  Responsibilities include leading regulatory submission projects, cross-functional team meetings, and FDA meeting activities.  In addition, Facet strongly supports and expects the Clinical Regulatory Affairs Director to be an active participant in service to the industry (e.g., industry memberships, conference presentations, or publications).

Success also requires strong interpersonal skills (e.g., good negotiation, conflict management), a willingness to ferret out information, manage constructive criticism proficiently, and an ability to analyze complex issues and distill them into simple yet compelling messaging.

This is a remote (work from home) full-time position.  To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Key Responsibilities:

• Serve as the primary liaison to FDA on behalf of Facet clients (US Agent)
• Lead/coordinate FDA meeting activities, including preparing clinical portions of meeting materials, facilitating team rehearsals, actively leading/participating in the FDA meeting, and performing meeting follow-up
• Design and implement US regulatory and clinical development strategies for investigational and FDA-approved products
• Prepare and review clinical sections of gap analyses
• Lead/contribute to the strategy and preparation of the clinical components of regulatory submissions (e.g., initial and maintenance of IND, NDA, BLA, IDE, 510(k), De Novo, PMA, or other regulatory applications based on your subject matter expertise)
• Establish key clinical messaging for regulatory submissions and work with the cross-functional team to ensure consistent clinical messaging within and across submission components
• Compile submission content for publishing and review and approve published submissions prior to dispatch to FDA
• Provide clinical and regulatory representation for Facet on various cross-functional teams
• Maintain timelines and work within the assigned contract budgets
• Be familiar and work in accordance with ICH and US Federal Regulations and Facet SOPs
• Contribute to the development and maintenance of Facet and departmental working practices and procedure
• May author, QC, and finalize clinical and regulatory submission documents, depending on skills, experience, and interests (e.g., IB, ICF, ISE, ISS, SCE, SCS, product labeling)

Experience and Skills Desired:

• Bachelor of Sciences required. Advanced degree in a scientific discipline (e.g., MS, Ph.D., PharmD, MD) or RAC strongly preferred
• At least 3 years of experience in a clinical regulatory affairs/strategy role required
• At least 1 year of experience interacting directly with FDA required. Experience with FDA meetings highly desirable
• At least 5 years of relevant pharmaceutical/scientific experience required
• Ability to analyze and interpret complex information (i.e., trial designs, statistical methods, trial results, medical information)
• Proficient in evaluating and accurately portraying conflicting information
• Ability to distill complex clinical information into clear, compelling, data-supported messaging
• Strong organizational skills and attention to detail
• Strong time management skills
• Expert in MS Word, Excel, and Power Point applications
• 21 CFR Part 11 document management experience desirable
• Consulting experience desirable

Benefits and Compensation:

We are a small company with big company benefits.  Providing great benefits to keep our Facet colleagues healthy and happy is a core value for us.  We provide our team members with top-notch benefits:

• health insurance plan
• supplemental insurance
• dental insurance
• life insurance
• short- and long-term disability insurance
• 401K program
• Several bonus programs
• Company-supported, required annual training
• Flexible work environment
• Unlimited sick and vacation