Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. 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. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
The Director of Regulatory Affairs will develop and implement regulatory strategies to support the development of oncology or hematology 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.
Key Accountabilities/Core Job Responsibilities:
- Develop and implement competitive and effective global regulatory strategies for oncology products and identify potential risks associated with proposed strategies
- Manage and participate in the creation, review, assembly and submission of regulatory documentation such as NDAs, INDs, and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials
- Coordinate and consult with subject matter experts on the content, review, and publication and assembly of regulatory documentation
- Serve as primary Health Authority contact for assigned projects
- Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes.
- Collaborate with business partners, regional and country regulatory affiliates/CROs, in order to support international development activities
- Coordinate/facilitate and prepare for Health Authority meetings and associated briefing document preparation
- Attend relevant functional area and project team meetings
- Ability to manage a team of RA (Sr) Managers and RA Associates
- Bachelor degree in a life sciences, medical sciences, or related discipline required. Advanced degree such as MS, PhD, PharmD strongly preferred.
- 8 to 12 years of experience in Regulatory Affairs (minimum 4 years within oncology desired) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
- Prior experience leading all aspects of (s) NDA or (s) BLA filings required
- Knowledge of current US and EU regulations for oncology drugs, 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
- Knowledge of oncology 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
- Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs) preferred
- 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.
- Ability to successfully manage multiple projects to deadlines
- Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies
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