Senior Director Regulatory Affairs, CMC

Location
Thousand Oaks, California
Posted
Sep 14, 2018
Required Education
Bachelors Degree
Position Type
Full time

Position Summary This position supports all CMC regulatory affairs activities for the company’s products and research, provides CMC regulatory input for regulatory strategies and RA CMC leadership within regulatory and on cross-functional CMC teams.  

 

Reports to                 Vice President Regulatory Affairs CMC

 

Location                     Westlake Village, (northwest Los Angeles area), CA

 

 

 

Primary Responsibilities

 

Leads the development of competitive regulatory strategies. Provides strategic and tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements. Manages assigned regulatory projects and closely collaborate with personnel from Clinical, Regulatory Operations, other scientific departments and external vendors to coordinate and implement submission strategy and content in a global clinical development environment. Serves as a liaison between the regulatory authorities and the company on CMC issues, successfully prepare teams, lead regulatory agency meetings. Manages the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate. Provides updates on strategic global regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc. Identifies and drafts necessary SOPs and/or Work Instructions for Regulatory Affairs. Contributes to the creation and maintenance of a Target Product Profile and Company Core Data Sheet. Provides regulatory intelligence to project specific regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios. Leads interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions. Collaborates with Regulatory Operations or publishing vendors to ensure that Atara’s practices are in conformance with the latest health authority and industry submission standards. Ensures logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding. Assists the teams with change control assessment in order to ensure that they meet regulatory requirements. Hires, leads, mentors and develops a team of direct reports. Performs other related duties as assigned.   

 

Travel             Travel may be required (up to 25%)

 

Physical Requirements Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.

 

 

 

Position Requirements

 

Strong leadership and management skills. Strong communication skills (e.g., clear and concise), team player, proven negotiation skills. Ability to manage and motivate staff. Demonstrated experience with global development, registration and post-approval submissions. Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology. Strong time and project management skills. Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary. Able to understand and interpret data/information and its practical application. Experience with hiring, coaching, developing and leading a team. Extensive knowledge of US and international regulatory requirements. Proficient in pertinent software & tools. Strong collaboration and cross-functional partnership building. Role model for Atara’s Values of patients first, innovation teamwork, community and mindset. Education and Professional Experience

 

Minimum of a Bachelor's degree, preferably in Sciences/Health Related Sciences, from an accredited college or university. 15 or more years of related pharmaceutical or biopharmaceutical industry experience, with at least 10 of those years directly in regulatory affairs. Must be knowledgeable in industry trends for study reports and global dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).