Ionis Pharmaceuticals, Inc.
Associate Director/ Director of Regulatory Affairs - Global Regulatory Lead
Ionis Pharmaceuticals, Inc., Carlsbad, California, United States, 92002
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!
ASSOCIATE DIRECTOR / DIRECTOR OF REGULATORY AFFAIRS - GLOBAL REGULATORY LEAD
The Associate Director / Director of 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 Vice President, Regulatory Affairs. This position will be the responsible RA lead for multiple compounds in development and work within cross-company development project teams, providing expertise in translating clinical and nonclinical 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, and through global regulatory agency interactions. 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 San Diego-based applicants.
RESPONSIBILITIES:
Ensure optimal acceptable regulatory strategies for worldwide compliance and submissions
Provide regulatory perspective and leadership to multiple project teams
Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, meeting briefing documents and marketing authorization applications
Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug approvals
Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
Identify relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execution
Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
Prepare information or responses as requested by regulatory agencies
Provide technical review of data or 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 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
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
Effectively lead and manage multiple time-sensitive projects
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,
www.ionis.com
for more information about Ionis and to apply for this position; reference requisition #IONIS003432.
Ionis offers an excellent benefits package!
The pay scale for this position is $146,300 to $236,156.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
#J-18808-Ljbffr
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!
ASSOCIATE DIRECTOR / DIRECTOR OF REGULATORY AFFAIRS - GLOBAL REGULATORY LEAD
The Associate Director / Director of 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 Vice President, Regulatory Affairs. This position will be the responsible RA lead for multiple compounds in development and work within cross-company development project teams, providing expertise in translating clinical and nonclinical 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, and through global regulatory agency interactions. 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 San Diego-based applicants.
RESPONSIBILITIES:
Ensure optimal acceptable regulatory strategies for worldwide compliance and submissions
Provide regulatory perspective and leadership to multiple project teams
Author and compile FDA and Ex-US regulatory applications and submissions, inclusive of general correspondence, INDs, CTAs, protocol and information amendments, annual reports, meeting briefing documents and marketing authorization applications
Lead preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug approvals
Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
Identify relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execution
Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review
Prepare information or responses as requested by regulatory agencies
Provide technical review of data or 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 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
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
Effectively lead and manage multiple time-sensitive projects
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,
www.ionis.com
for more information about Ionis and to apply for this position; reference requisition #IONIS003432.
Ionis offers an excellent benefits package!
The pay scale for this position is $146,300 to $236,156.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
#J-18808-Ljbffr