Senior Manager, Regulatory Operations

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
SENIOR MANAGER, REGULATORY OPERATIONS
The Senior Manager of Regulatory Operations is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of clinical programs as well as commercial filing efforts. 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 Assistant Director, Regulatory Operations.
Responsibilities
The Senior Manager of Regulatory Operations will be responsible for planning and managing the 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 some initial submission documents and maintenance submission documents, such as annual reports, periodic safety update reports, safety reports, investigator information updates and clinical study reports. Additionally, this person may support global commercial filing efforts and post-approval submissions activities. The individual will manage, in close collaboration with Regulatory Affairs personnel, the generation of regulatory submission content and the submission timelines. He/she will be responsible for coordinating the formatting and publication of submission documents and overseeing or 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 early-stage clinical development programs. He/She will serve as the point of contact for internal and external collaborators regarding submission development. In addition, this person will also assist clinical study team with start-up activities such as essential regulatory document review.
Requirements

• Experience with Global CTA submissions, especially to Canada and EU Countries.
• 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
• Experience leading the management of projects/timelines and collaborating with team members
• Expertise in the use of document management and eCTD publishing systems
• Bachelor’s degree, scientific field preferred
• Experience with Phase 3 and newly approved products is desirable.
• Excellent oral and written communication skills
• Minimum of 5 years prior experience in a Regulatory Operations group within the industry, Pharmaceutical or Biotech Company preferred.
• Excellent negotiation and relationship development skills to effectively interact with vendors and corporate partners
• Expertise in eCTD format and regulatory submission requirements
• Proven ability to manage, streamline and collaborate to improve document preparation and management systems
• An ability to be productive and successful in an intense work environment
• Demonstrated advanced leadership, problem solving and organizational skills

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003121
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $87,845 to $119,637
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.