Position Summary:

Reporting to the Executive Director of Regulatory Affairs and Quality Assurance, this position will provide strategic and operational expertise to support submissions to the FDA and other Health Authorities. The Director, Regulatory Affairs will be an integral and highly visible contributor to the team. This person should be a motivated, self-starter with experience in leading IND/CTA submissions to support late-stage clinical development.

Essential Duties/Responsibilities:

• Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings.
• Lead multidisciplinary teams in the development and authoring of major regulatory documents (e.g Meeting Briefing Packages, Breakthrough Therapy Designation Requests).
• In collaboration with the team, develop response strategies and submissions to Health Authorities
• Lead and facilitate activities, including team preparation, for meetings with FDA, EMA and other regulatory authorities.
• Author, review and provide strategic input on regulatory filing documents (e.g. eCTD Module 2 summaries, clinical protocols, Investigator’s Brochure).
• Liaison responsible for communication with FDA and other Health Authorities for assigned programs.
• Interface with partners, Contract Research Organizations and consultants as needed.
• In collaboration with team, perform/manage critical analyses of FDA and ICH guideline and independently develop strategic/tactical interpretation and implementation.
• Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
• Develop and implement regulatory SOPs and common work practices/strategies within the team.

Job Requirements

· Bachelor’s degree in life sciences or related field or equivalent experience required; advanced degree and/or certifications are a plus.

· Minimum 10 years of pharmaceutical industry experience, at least 7 of which should include direct experience in Regulatory Affairs

· Extensive knowledge of GxP regulations and guidelines

· Experience with development of NCEs (in oncology preferred)

· Experience in successfully filing INDs and CTAs

· Strong organizational, problem-solving, and priority management skills

· Excellent interpersonal and communication skills (both written and oral)

· Occasional travel

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, stand, walk, push, pull, talk, and hear with extended amounts of time in front of a computer. The employee is occasionally required to reach with hands and arms; and stoop, kneel, or crouch. The position requires clarity of vision, both close and far; hand/eye coordination; the ability to identify and distinguish colors; and the use of hands and fingers to type, sort, and handle. Also required is the ability to reason and calculate; the ability to retain and recall information; the ability to convey information quickly and accurately; and the ability to lift or move up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Environmental Conditions:

While performing the duties of this job, the employee may be exposed to the following environmental conditions: biological hazards, toxic or caustic substances, blood borne pathogens, zoonotic disease, high magnetic field, noise, unpleasant odors, and risk of radiation.

Position Type/Expected Hours of Work:

This is a full-time position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand. Travel is less than 10 percent.

Supervisory Responsibilities:

This position requires the ability to interact with all levels of employees. It does not require direct supervisory responsibilities.

Competencies:

• Communicate in English, both orally and in writing (communication skills)
• Organize, analyze, and interpret data (critical thinking)
• Exhibit attention to detail (critical thinking)
• Plan effectively (project management; planning and organizing)
• Demonstrate creativity and resourcefulness (problem solving)
• Understand and follow directions (technical capacity)
• Make decisions and take appropriate actions (influencing and leading)
• Work as a member of a team as well as independently (teamwork and negotiation)
• Remain flexible and reliable (teamwork and negotiation)
• Work under steady pressure with frequent interruptions (stress tolerance)
• Handle stressful situations (stress tolerance)
• Apply effective time management skills (time management)
• Exercise good judgment and maintain confidentiality (ethical conduct)
• Follow and apply appropriate laws, regulations, policies, and procedures (ethical conduct)

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer