Director/ Senior Director, Clinical Regulatory Affairs

Employer
Nkarta Inc
Location
South San Francisco, CA, United States
Posted
Oct 13, 2020
Ref
30410
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Director/ Senior Director, Clinical Regulatory Affairs

Nkarta is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer (NK) cell therapies to treat cancer. Nkarta seeks to improve upon the efficacy of cell therapy, making it more potent, better tolerated and more rapidly available to a broad population of patients with a variety of hematologic and solid tumor malignancies.

Nkarta is currently seeking a qualified, highly motivated, experienced individual for the position of Director/ Senior Director, Clinical Regulatory Affairs. The successful candidate will provide leadership on global regulatory activities for cellular immunotherapy development products in Nkarta's pipeline. Responsibility includes nonclinical, clinical, and CMC regulatory submissions and providing strategic as well as operational leadership on the project teams in these areas. The candidate will develop regulatory strategies and manage IND/BLA submissions, FDA and other regulatory interactions, as well as international submissions, for assigned product candidates. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this role.

Organizational Hierarchy:

The Director/Sr. Director, Clinical Regulatory Affairs is a member of the Regulatory organization.

This position reports to the VP, Regulatory Affairs and Clinical Quality.

Responsibilities:

• Develop regulatory strategic plans in conjunction with project teams and assist in the design of nonclinical and clinical study programs required for regulatory approval

• Lead filing teams for IND/CTA/BLA/MAA submissions, setting strategy for submissions of product registration documents for health authorities worldwide

• Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions

• Provide interpretation of regulatory authority feedback, policies, and guidelines to Nkarta personnel, and serve as a liaison between Nkarta and regulatory authorities

• Represent Nkarta before regulatory authorities on designated programs

• Work with project teams to resolve complex project issues

• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained

• Effectively plan, organize, and conduct in close collaboration with leads from other functional areas formal meetings with regulatory agencies

• Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of INDs/CTAs/marketing applications

• Provide organizational support and be prepared to manage personnel as company grows its product development pipeline

Core Competencies, Knowledge, and Skill Requirements

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgement; honesty, integrity, and trust-building behaviors in all dealings is essential

• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction

• Daily demonstrates a positive, ‘can do' and service-oriented attitude

• Strong oral and written communication skills; adaptable to different audiences

• Detail-oriented with a commitment to accuracy

• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks

• Ability to multi-task and shift priorities quickly while working under tight deadlines

• Skilled in developing collaborative internal and external relationships

• Strong computer skills and proficiencies in standard applications (MS Office suite)

Education and Experience

• B.S. in life sciences or other relevant field; advanced degree preferred

• 10 - 15 years of biopharmaceutical, which includes at least 10 years of direct experience in Regulatory Affairs with successful BLA/MAA filing experience

• Cell therapy and oncology experience preferred