6 to 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience preferred Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred Knowledge of current US and EU regulations, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs) Senior Manager/Associate Director, Regulatory Affairs JOB DESCRIPTION:
Client is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies.
More than 1,000 scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites.
They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments
Oncology is a key therapeutic area for, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
The Senior Manager /Associate Director, Regulatory Affairs will develop and implement global regulatory strategies to support the development of multiple oncology early development assets.
This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.
This position is based in the Redwood City, CA location.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Coordinate and prepare for Health Authority meetings and associated briefing document preparation
Present global regulatory strategies and issues at team or governance meetings
Serve as primary Health Authority contact for assigned projects
Manage and participate in the creation, review, assembly, and submission of regulatory documentation such as INDs and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials
Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
Coordinate and consult with subject matter experts on the content, review of publication/promotional materials, and assembly of regulatory documentation
Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes.
Collaborate with regional and country regulatory affiliates to support international development activities
Attend relevant functional area and project team meetings, including nonclinical, clinical, and regulatory sub teams
Ability to successfully manage multiple projects to deadlines
Experience with health authority meeting preparation
Knowledge of global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements
Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies