VP/SVP, Head of Regulatory and Quality - Los Angeles, United States - GQR

Description

Our client is a small, public, clinical-stage biotech developing biologic treatments for rare and immunological diseases.

About the job

This position will be the Head of Regulatory and Quality, overseeing both functional areas across the entire company pipeline, and reporting directly to the Chief Development Officer.

Responsible for providing primarily global regulatory leadership and direction in support of the development, registration, and life-cycle management of innovative programs in immunology, nephrology, and rare diseases.

The individual will provide oversight of the content and preparation of all regulatory documents/submissions related to applicable programs and lead two junior members of the regulatory team.

They should also have past experience overseeing a Quality function. Though hands-on experience in Quality is not necessary, they should be able to lead the function and those reports.

Responsibilities

• Provides regulatory leadership in support of the development, registration, and life-cycle management of products (both early-stage and late-stage development)
• Provides strategic regulatory direction on programs to support a global pipeline
• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables
• Provide critical review of documents related to clinical and nonclinical aspects of programs to ensure messaging is consistent with program strategy
• Maintain knowledge of and monitor changes in current global rules and regulations governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
• Initiate or contribute to local and/or global process improvements which have a significant impact on business.

Requirements

• Minimum BA/BS degree in life sciences. Advanced degree preferred.
• Strong scientific background with at least twelve (12) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Proven ability to successfully manage major submissions and critical projects to deadlines.
• Proven ability to successfully interact with regulatory authorities.
• Experience in the preparation and filing of marketing applications is desirable
• Experience with development of drugs/biologics for immunology, nephrology, rare or infectious diseases is preferred.

To be considered for this position, please send your resume along with your application. Suitable candidates will be contacted with more information before their resumes are submitted to the client.

#J-18808-Ljbffr