Senior Regulatory Affairs Associate
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 specific regulatory documents preparation, review and submission, and assist with compliance issues. Performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Keeps abreast of regulatory procedures and changes. Key Accountabilities/Core Job Responsibilities:
- Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (i.e, INDs, CTAs, NDAs, Orphan Designations) including prepare, coordinate and review multiple submissions and projects effectively. Ensure consistency, completeness and adherence to standards for all regulatory submissions.
- Participate in the study management & collaborate with regulatory operations as it relates to all regulatory submissions
- Execute, with appropriate guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
- Acquires and maintains thorough knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects
- As required, support study managers per assigned product teams as it relates to attendance and participation at study team meetings
- Support study managers for major filings (e.g., sNDA) with emphasis on Module 1 deliverables requiring coordination with other functions accordingly
- Ability to work either independently with minimal direction separately or within project teams, committees, etc. to attain group goals
- Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
- Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
- Computer literate
- 2 years medical device/pharmaceutical/biotechnology industry experience
- Experience and/or knowledge in the preparation of INDs, ex-US CTAs and all supportive amendments or supplements
Education Requirements (i.e. degree, certifications):
- Minimum of a BA/BS in a scientific, healthcare or related field