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Atara is seeking a Vice President, Regulatory Affairs who will be responsible for the timing/sequencing of regulatory milestones as well as the preparation, review and evaluation of documents for submission to health care regulatory authorities. The ideal candidate will be a strategic, dynamic, highly collaborative, and successful senior executive who can leverage the science and brings significant global regulatory leadership experience in both development programs and marketed products.
Specific responsibilities include:
Provide leadership in the design and execution of strategies for complex regulatory submissions in close collaboration with other company functions.
Provide regulatory guidance for the planning and compilation of critical documentation related to U.S. and worldwide submissions; Manage and prepare regulatory documents and submissions in accordance with business strategies; Compile and author documents for submission to regulatory agencies, including premarket notification submissions and pre-market approval applications This will include hands on contributions and leadership on documents such as, (INDs, NDAs,/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, etc.)
Direct the strategy (time, tone, and content) of interactions with the respective regulatory health authorities’ including the request, preparation and execution of meetings with regulatory authorities for product specific issue and policy related issues.
Interpret regulatory requirements for company filings.
Interpret changes in regulatory landscape and communicate impact to senior leadership.
Keep management informed of regulatory status of products and significant regulatory issues.
Represent Atara before regulatory authorities. He/she should have strong working relationships with key regulatory authorities.
Interact and collaborate with regulatory agency personnel in changes to regulation.
Ensure corporate compliance for manufacturing licenses, government reporting requirements, and global labelling.
Provide technical regulatory input to business development and collaboration opportunities.
As the company grows, build a strong regulatory affairs team to meet regulatory needs.
Develop and mentor regulatory staff/personnel.
Represent regulatory group with internal and external partners.
Work with reimbursement specialists to determine U.S. and international regulatory and reimbursement strategies.
Proactively influence regulatory policies and implement processes to ensure company maintains market status.
Be an active member of industry associations.
15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry.
Bachelor’s degree in Chemistry, Biochemistry, or related pharmaceutical science is required; advanced degree is desirable.
Extensive prior experience in the successful filing of regulatory submissions is required.
Experience presenting on clinical programs, negotiating, and gaining marketing approval with the FDA and Ex-US Regulatory Authorities.
A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines. Affinity with the science and ability to interact with scientists is key.
Ability to speak and interact with a diverse group of individuals on technical and business topics. Proven ability to make data-based decisions is preferred.
Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena, including the US, EU, and Japan.
Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
Outstanding presentation, written and verbal communication skills required. A clear communicator who can influence stakeholders effectively, both internally and externally.
Proven ability to lead and manage complex global projects to successful completion.
Flexibility/agility to respond to Atara’s evolving business needs.
Strong ability to influence and gain credibility with both internal and external key stakeholders.
Ability to manage in a consensus environment through teamwork, trust and shared expectations. The successful candidate will be an individual who can influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
Ability to build collaborative relationships both internally and externally.
Ability to inspire, motivate and develop regulatory team and members.
A track record of successful interactions among regulatory and health authorities on an international level.
Demonstrated advocacy and negotiation skills
Ability to prioritize and handle multiple projects simultaneously.
Strong project management and computer skills.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers and staff.
Humility, good judgment and strong analytical skills, with an ability to adjust quickly to changes
A high level of integrity, responsibility, and honesty.
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