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Manager, Regulatory Affairs

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: July 14, 2019

Job Description:

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: Responsible for the development and implementation of regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development to which the role is assigned. This individual assists Regulatory Staff by identifying and gathering data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory requirements. Advises on region specific requirements and assesses R&D programs against region specific regulatory requirements Responsibilities:

  • Responsible for a product(s) within a Therapeutic Area and supports more senior regulatory management in the development & execution of the regulatory strategy. Assigned matters may have an impact on business activities and operations.
  • Serves as Health Authority (HA) liaison with FDA for routine communications in support of filings including complete and timely responses during application review. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. Functions independently in negotiation and decision making for project related issues that have cross-functional impact.
  • Key contributor responsible for the preparation and review of regulatory submissions consistent within applicable regional regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
  • Supports the regulatory submission and approval process. Applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of regional government regulations, guidances, as well as corporate policies and management-related considerations.
  • Presents pertinent regulatory information to appropriate cross-functional areas.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP). Qualifications:
    • Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry related.
    • Preferred Education: Advanced Degree a plus. Certifications a plus.
    • Required Experience: 5 years Regulatory, R&D, or Industry-related experience.
    • Preferred Experience: 2-3 years specific to pharmaceutical regulatory activities to include knowledge in the preparation of IND/CTAs, NDAs, and all supportive amendments or supplements.
    • Skill Set: Proven skill at implementing successful regulatory strategies, global regulatory
    • experience is a plus. Experience working in a complex and matrix environment.
    • Skill Set cont'd: Good communication, both oral and written. Experience interfacing with government
    • regulatory agencies. Demonstrates good negotiation skills and builds consensus. #LI-SH26 #featuredjob Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Keywords: Pharmacyclics, LLC, Sunnyvale , Manager, Regulatory Affairs, Executive , Sunnyvale, California

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