Manager/ Senior Manager, Regulatory Affairs

Ionis Pharmaceuticals; Carlsbad (CA); Remote; USD 72,000 - 129,000; Full time

Job summary

Ionis Pharmaceuticals is seeking a Manager/Senior Manager for Regulatory Affairs to develop regulatory strategies and support drug development. This role involves ensuring compliance with regulations and working with cross-functional teams. A Bachelor's degree and relevant experience are required.

Benefits

Excellent benefits package

Qualifications

• 2-5 years of Regulatory Affairs experience.
• Solid working knowledge of domestic and global regulations.

Responsibilities

• Develop regulatory strategy and support drug development projects.
• Coordinate regulatory filings and ensure compliance.
• Provide regulatory guidance to cross-functional teams.

Skills

Analytical Thinking

Communication

Team Player

Problem Solving

Education

Bachelor’s 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’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

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

MANAGER / SENIOR MANAGER, REGULATORY AFFAIRS

SUMMARY:

The Manager / Senior Manager, 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 Director, Regulatory Affairs. Incumbent will work with the cross-functional franchise project teams and support multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and provide expertise in translating clinical and non-clinical 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. Experience with rare disease/orphan drug development and/or cardiovascular or neurology targeted therapeutics is a plus.This position may be fully remote, however preference will be given to applicants who are local to San Diego (and surrounding areas).

RESPONSIBILITIES:

• Work with global regulatory lead in planning, preparation, and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.) in line with global development strategies
• Support the development and execution of regulatory strategies to advance assets (preclinical through Phase 3) in-line with company objectives and global/local regulations
• Evaluate and interpret regulatory precedents and global regulatory requirements to inform and support product development strategies and decision-making.
• Proactively liaise with functions and participate as a member of cross-functional teams to provide regulatory guidance and direction to accomplish results aligned with company objectives
• Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
• Provide technical review of data and 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
• Ensure Ionis regulatory documentation is maintained appropriately
• Exercise outstanding judgment in all areas of responsibility
• Other duties as assigned

REQUIREMENTS:

• Bachelor’s Degree with at least two years or more 5 years of similar related Regulatory Affairs experience
• Solid working knowledge of relevant domestic and global regulations and guidance
• Experience in drug regulatory affairs, development activities and clinical activities
• Energetic, self-motivated and a hands-on professional with strong work ethic
• Ability to perform and think analytically and creatively to solve problems
• An ability to multi-task, lead and manage multiple time-sensitive projects
• Ability to be a true team player working for the common goals of Ionis and have the excellent communication and interpersonal skills required to enable optimal interaction with intramural teams
• An ability to be productive and successful in an intense work environment

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003694

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

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

The pay scale for this position is $72,871 to $128,043

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.