Location:Redwood City, California, United StatesJob reference:
Oct. 25, 2016
Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
Reporting to the [Director/Sr Director] of Regulatory Affairs, the Senior Manager Regulatory Affairs will oversee day-to-day regulatory activities of assigned projects. These activities include preparation and compilation of submissions for regulatory agencies, serving as regulatory representative for assigned clinical studies, management of regulatory submissions processes and timelines, and oversight of various regulatory tracking tools, archives, and infrastructure, as assigned.
The Senior Manager Regulatory Affairs is responsible for collaborating with the Project Team representatives in compilation of submissions to regulatory agencies, including coordination with regulatory operations group. For larger submissions, collaborates with project management organization to set and track submission timelines. As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, oversees clinical trial application activities, reviews and approves investigator document packages, and manages other regulatory aspects of study as directed. Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments.
Additionally, the Senior Manager Regulatory Affairs will collaborate with Project Team representatives in planning of regulatory documents, including authorship of discrete document sections, definition of review cycles, as well as adjudication of review comments, as assigned. Oversees process by which regulatory submissions are reviewed, finalized, and signed-off. Builds effective partnerships -- identified opportunities and takes actions to build effective relationships within team and with other areas. Manages tracking of regulatory/ethics submissions and approvals across all studies. Provides regulatory review of clinical, nonclinical, manufacturing, and regulatory documents as directed. Conducts regulatory intelligence on therapeutic landscape and regulatory developments, provides updates to regulatory and project teams as needed. Authors and reviews work instructions and SOPs for department as assigned. Consistently complies with all governing laws, regulations, Acerta Pharma SOPs and other guidelines. Has personal responsibility for maintaining a culture of high competence, creativity and collaboration.
* Minimum BA/BS degree in the biological or physical sciences
* PharmD, PhD or equivalent preferred (Minimum requirements are flexible for candidates holding advanced scientific degrees) .
* 3+ years experience in the biotech/pharmaceutical industry
* 3+ years of experience in regulatory affairs
* Knowledgeable of international pharmaceutical guidances, regulations, drug development process, and industry standard practices
* Highly proficient in written, oral, and interpersonal communications in English
* Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
* High attention to detail; ability to organize, prioritize, and delegate assigned projects
* Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations
* Proficient user of standard MS Office suite (e.g.., Word, Excel), experience using electronic document management systems and document review tools preferred
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.