Position Description: Sr. Manager/Associate Director Regulatory Affairs - Biologics

Job Title | Sr. Manager/Associate Director Regulatory Affairs - Biologics
Location | La Jolla, CA
Department | Regulatory Affairs

Summary

Manage regulatory projects for biologic cell-based products, including major, complex applications submitted to global regulatory agencies. Develop effective proactive regulatory strategies for global product development with limited oversight. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Incumbent may lead and assist in assessing, coaching, and developing the Regulatory Affairs and project teams. Ensure appropriate partnering within the business, including Medical, Quality, Marketing, and Operations. Title will be commensurate with experience.

Essential Duties and Responsibilities

The duties and responsibilities of this position include the following, although other duties may be assigned.

• Lead/manage complex projects which requires coordination of cross-functional resources and strategic management of competing priorities that have a direct impact on site operation.
• Provide input and review of regulatory requirements, project risks, and prepare submissions and facilitate their approval. Manage resources for submission preparation and communication with internal/external customers to achieve all phases of product approval and commercialization of products.
• Participate in project teams to manage activities and/or changes related to product development, manufacturing, and commercialization. Provide review of and input to development plans. When appropriate, provide strategic guidance for problems being discussed and recommend solutions.
• Support review of safety reports; prepare and submit adverse event reports as required to the FDA and/or appropriate government agencies.
• Hands-on RA representative on product development teams. Coaches others on technical, scientific, and clinical aspects of regulatory submissions and facilitates the sharing of critical research and development information.
• Identifies and drives continuous improvement in support of quality standards and business results. Provide guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols. Guides and coaches others in the appropriate application of regulations and standards related to submission preparation and commercialization, product and labeling compliance.
• Review product labeling and advertising materials for compliance with approvals and applicable global regulations; analyze and recommend appropriate changes.
• Collaborate with Quality Assurance to manage programs and ensure regulatory compliance with product development, validation, and commercialization activities subject to regulations established by US, EMEA, and other worldwide governments (as required).
• Interact with outside consulting groups and manage activities necessary for completing key initiatives. Provide mentoring to current staff and have skill sets for directly managing staff.

Supervisory Responsibilities

Position has supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

BS degree in life sciences or related scientific discipline, prefer advanced degrees. A minimum of 10 years of relevant experience in the biotech industry required; a minimum of 6 years regulatory experience in develop strategies, planning and publishing regulatory submissions required. Regulatory experience with development of Biologic products required and proven experience with IND and BLA submissions and negotiations with FDA staff. Experience with working on clinical studies across the regulatory spectrum from Phase I to post-approval.

Must have a good working knowledge of relevant regulations.

Previous manager-level experience, including supervisory experience required. Strong organizational, interpersonal and written/verbal communication skills.

Preferred Experience:

• Experience with the development of cell-based products a plus
• Experience with the development of products in the area of tissue repair/regenerative medicine with an emphasis in soft tissue/orthopedics

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Certificates, Licenses, Registrations

RAC certification preferred.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Normal office environment.

We offer a competitive benefits & compensation package!

All qualified resumes should be submitted directly to careers@abh.com

We are an Equal Opportunity Employer.