||Associate Director/Director, Regulatory Affairs
Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we
must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.
ASSOCIATE DIRECTOR / DIRECTOR, REGULATORY AFFAIRS
The Associate Director/ Director, Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution. This is an individual contributor role, reporting to the Senior Director, Regulatory Affairs.
This position will work within cross functional development project teams and will provide expertise in translating clinical and nonclinical regulatory requirements into practical strategic regulatory plans. This individual will implement these plans through
coordination, authorship and development of domestic and international drug applications and submissions, and through regulatory agency interactions.
- In conjunction with RA department leadership, ensure optimal acceptable regulatory strategies for worldwide compliance and submissions, in an environment committed to the efficient development of new drugs for patients
- Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, meeting briefing documents and NDAs
- Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug development and drug approvals
- Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
- Identify relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure they are implemented into development planning and execution
- Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
- Prepare information or responses as requested by regulatory agencies
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- Review clinical protocols to ensure collection of data needed for regulatory submissions
- Review safety reports and file all required SAE reports in accordance with regulatory agency guidelines
- Ensure regulatory documentation is maintained appropriately
- Other duties as assigned
- Bachelor’s Degree required; advanced degree preferred
- At least 8 years of increasing Regulatory Affairs experience and responsibility
- Solid working knowledge of relevant domestic and global regulations and guidance
- History of successful interactions with global regulatory authorities
- Energetic, self-motivated and a hands-on professional with a strong work ethic
- Ability to perform independently and think analytically and creatively to solve problems
- Effectively lead and manage multiple time-sensitive projects
- Ability to be a true team player working toward common goals
- Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
- An ability to be productive and successful in an intense work environment
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition # 14-0051
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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