Director of Regulatory Affairs - Global Regulatory Lead

Ionis Pharmaceuticals; Carlsbad (CA); Remote; USD 171,000 - 231,000; Full time

Job summary

An established industry player is seeking a Director of Regulatory Affairs to lead the commercial regulatory strategy for their first wholly owned program. This role offers the chance to work within cross-company teams, contributing to high-quality regulatory submissions and compliance efforts. With a focus on innovation and scientific excellence, this position allows you to make a meaningful impact on patients' lives while fostering your career in a supportive environment. If you are passionate about regulatory affairs and eager to drive success in a dynamic field, this opportunity is perfect for you.

Benefits

Excellent benefits package

Flexible work environment

Opportunities for career development

Qualifications

• 10+ years of Regulatory Affairs experience required.
• Strong knowledge of global regulations and guidance.

Responsibilities

• Lead regulatory strategy for drug approvals and compliance.
• Communicate with FDA and regulatory authorities effectively.
• Author high-quality regulatory applications and submissions.

Skills

Regulatory Affairs

Regulatory Strategy Development

FDA Communication

Technical Review

Project Management

Analytical Thinking

Interpersonal Skills

Team Collaboration

Education

Bachelor’s Degree

Advanced Degree

Job description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!

DIRECTOR OF REGULATORY AFFAIRS - GLOBAL REGULATORY LEAD

SUMMARY:

Director of Regulatory Affairs will lead the commercial regulatory strategy for Ionis’ first-ever wholly owned commercial program. This is an individual contributor role, reporting to the Executive Director, Regulatory Affairs. This position will work within cross-company development and commercial project teams, providing expert strategic regulatory plans, contributing to high-quality sNDA and MAA filings and responses, and contributing to the life-cycle commercial regulatory compliance. This individual will implement these plans through coordination, authorship and development of domestic and international drug applications and submissions, and through global regulatory agency interactions. Experience with cardiovascular targeted therapeutics is a plus. Experience as a commercial regulatory lead is strongly preferred. This position may be fully remote, however preference will be given to San Diego-based applicants.

RESPONSIBILITIES:

• Formulates and implements creative and robust regulatory strategies and activities needed to secure approval of new drugs and indications and ensure life-cycle maintenance and compliance.
• Serves as primary communicator with FDA and other regulatory authorities building effective relationships; communicates outcomes to senior management as appropriate.
• Provides regulatory advice to other functional areas and serves as key regulatory interface with the Project and Commercial Brand Teams.
• Provides technical review of data or reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Authors and compiles high-quality FDA and Ex-US regulatory applications including sNDA, marketing authorization applications, annual reports, etc; Prepares information or responses as requested by regulatory agencies.
• Leads preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug approvals.
• Maintains relationships and collaborates with partners to drive high-quality submissions; Works with multiple business partners to support Ex-US commercialization efforts.
• Effectively coordinates with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.
• Identifies relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execution.
• Ensures regulatory documentation is maintained appropriately.
• Other duties as assigned.

REQUIREMENTS:

• Bachelor’s Degree required; advanced degree preferred
• At least 10 years of increasing Regulatory Affairs experience and responsibility
• Solid working knowledge of relevant domestic and global regulations and guidance
• Experience filing marketing authorization applications (MAA) and supplemental New Drug Applications (sNDA) preferred
• Experience as Global Regulatory Lead (GRL) for a commercial product preferred
• Exercise outstanding judgment in all areas of responsibility
• History of successful interactions with global regulatory authorities
• Energetic, self-motivated and a hands-on professional with a strong work ethic
• Able to perform independently and think analytically and creatively to solve problems
• 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
• Willing to travel domestically and internationally up to 15%

Please visit our website for more information about Ionis and to apply for this position; reference requisition #IONIS003453.

Ionis offers an excellent benefits package! Follow this link for more details.

The pay scale for this position is $171,606 to $231,000.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.