Assistant/Associate Director of Global Regulatory Advertising/Promotion and Labeling Compliance
Location
Carlsbad, CA | United States
Job description
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.
ASSISTANT/ASSOCIATE DIRECTOR OF GLOBAL REGULATORY ADVERTISING/PROMOTION AND LABELING COMPLIANCE SUMMARY: The Asst/Associate Director Director, Regulatory Advertising/Promotion and Labeling Compliance, serves as the Regulatory Affairs (RA) representative on product promotion review teams and project teams as applicable to contribute to the content of product labeling. The Asst/Associate Director has responsibility for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications and driving the strategic development of labeling on both actively marketed products as well as innovative, development products at the global level. The Asst/Associate Director will support the product leads for execution of labeling strategies including, but not limited to, supporting the management of the global product label content process at Ionis and support the Regulatory Product Leads and Project Teams in the development of company core datasheets (CCDSs), clinical and commercial labeling globally. this indiviudal will advise on the regulatory strategy and provide direction to the product labeling teams. The Asst/Associate Director will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials and Labeling. The Asst/Associate Director may also acts as the primary liaison with FDA on regulatory issues concerning promotional materials and Labeling.
RESPONSIBILITIES: - Reviews US promotional, disease awareness, public affairs and medical materials and ISTs, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
- Participate in cross-functional team to formalize the process for review of promotional materials outside of the US
- Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
- As needed, provides training support on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
- Drives labeling process and strategy for the development, lifecycle management, and implementation of CCDS and labeling (i.e., prescribing/patient information and packaging/artwork) in all markets to support successful commercialization. Establishes labeling strategy through regulatory guidance, health authority feedback, and historical experience/labeling negotiations.
- Assist with the production of new labeling text in conjunction with Regulatory Strategy Leads and Strategists. Ensure that new labeling text meets regulatory labeling requirements.
- Facilitates cross-functional labeling review and approval of proposed labeling prior to submission of labeling to health authorities.
- Manages the preparation of submission-ready labeling and artwork components for different markets. consults with Regulatory Liaisons/CRO’s regarding Health Authority requirements and evolving internal and external submission and negotiation plans.
- Supports Health Authority labeling query responses and coordinates cross-functional alignment and approvals to address Health Authority requests in a timely manner.
- Maintains accurate files of labeling change history and associated documents, including annotated labels back to source data.
- Contributes to the development of continuous improvement of business practices associated with AD/Prom and labeling processes and tools.
COMPETENCIES IDENTIFIED FOR SUCCESS - Solid working knowledge of U.S. advertising/ promotional and Labeling regulations
- Direct experience communicating and negotiating directly with Regulatory Authorities
- Experience with global standards for advertising and promotion compliance
- Demonstrated understanding of regulations, processes and issues in drug development. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH, FDA, EMEA, NICE and other relevant guidelines
- Proven track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Strong interpersonal, communication and leadership skills.
- Proven ability to prioritize and meet critical business timeline
REQUIREMENTS: - Bachelor's’ Degree
- Minimum 8+ years of pharma experience
Please visit our website, for more information about Ionis and to apply for this position; reference requisition # IONIS003356
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis Benefits Full Benefits Link: The pay scale for this position is $124,025 to $199,827
NO PHONE CALLS, PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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