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.
Established as a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense
MANAGER, REGULATORY OPERATIONS
The Manager, Regulatory Operations is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of Phase 3 clinical programs. The position requires participation in and supervision of formatting, publishing, compilation
and submission of all regulatory documentation to domestic (FDA) and international regulatory agencies. This individual will be a key member of matrixed project teams, maintain submission-planning timelines for assigned submissions, and implement submission
strategies. This position reports to the CMO.
The Manager, Regulatory Operations will be responsible for coordinating the formatting and publication of submissions to regulatory agencies such as investigational new drug applications (IND) and Clinical Trial Applications (CTA) and all documents provided
therein (Quality Overall Summary/IMPD/Clinical Protocol/Investigator’s Brochure). This position will also be responsible for the document development of maintenance submissions to these applications such as annual reports, periodic safety update reports,
safety reports, investigator information updates and clinical study reports. The individual will manage, in close collaboration with Regulatory Affairs personnel at Ionis Pharmaceuticals, the generation of regulatory submission content and the submission
timelines. He/she will oversee and execute publication activities in both the eCTD and paper format and will utilize the corresponding document management, authoring, and publishing tools, and will perform other duties as assigned.
This individual will participate as an active member of multi-disciplinary teams, ensuring appropriate and effective communication to facilitate submissions in support of late stage clinical development programs. He/She will serve as the point of contact
for internal and external collaborators regarding submission development.
- Bachelor’s degree, scientific field preferred
- Minimum of 5 years prior experience in a Regulatory Operations group for a Pharmaceutical or Biotech Company
- Experience with Global CTA submissions, especially to Canada and EU Countries.
- Experience leading the management of projects/timelines and collaborating with team members
- Expertise in eCTD format and regulatory submission requirements
- Expertise in the use of document management and eCTD publishing systems
- Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems
- Previous experience developing work instructions and generating SOP’s that are consistent with global regulatory requirements and company business practices
- Proven ability to manage, streamline and collaborate to improve document preparation and management systems
- Excellent negotiation and relationship development skills to effectively interact with vendors and corporate partners
- Demonstrated advanced leadership, problem solving and organizational skills
- Excellent oral and written communication skills
- An ability to be productive and successful in a cross company environment
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #15-0104
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. are proud to be EEO employers.