BioSpace
Associate Director, Regulatory Operations and Intelligence
BioSpace, Salt Lake City, Utah, United States, 84193
Associate Director, Regulatory Operations and Intelligence
Join to apply for the
Associate Director, Regulatory Operations and Intelligence
role at BioSpace.
Overview Your work will change lives. Including your own. The Impact You’ll Make: We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and the organization updated with latest regulatory trends. This role also involves managing regulatory submission and publishing systems used in Regulatory Affairs.
Responsibilities
Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary.
Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing.
Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies.
Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. Update interactive trackers regularly.
Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.).
Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.
The Team You’ll Join Reporting to the Vice President, Regulatory, you’ll be an integral part of the regulatory team leading regulatory operations and intelligence function. You’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs in alignment with regulatory strategy, along with leading the intelligence function to disseminate impact from regulatory changes across different regions.
The Experience You’ll Need
Master’s or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
7+ years of industry-related experience in a regulatory publishing function.
5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo).
Experience with setting up regulatory intelligence functions and tools is a must.
Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
Experience interacting with health authorities for operational systems is preferred.
Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
Critical thinker with excellent attention to detail.
Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
Experience in project management is a plus.
Working Location & Compensation This is an office-based, hybrid role in Salt Lake City / New York City. Employees are expected to work in the office at least 50% of the time.
Based on the skill and level of experience required for this role, the estimated current annual base range is
$175,400 - $206,400 (USD) . You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
The Values We Hope You Share
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Learn more at www.Recursion.com, or connect on LinkedIn.
Equal Opportunity Employer Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Note Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. Any resume submitted by an agency without a signed agreement will automatically become the property of Recursion.
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Associate Director, Regulatory Operations and Intelligence
role at BioSpace.
Overview Your work will change lives. Including your own. The Impact You’ll Make: We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and the organization updated with latest regulatory trends. This role also involves managing regulatory submission and publishing systems used in Regulatory Affairs.
Responsibilities
Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary.
Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing.
Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies.
Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. Update interactive trackers regularly.
Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.).
Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.
The Team You’ll Join Reporting to the Vice President, Regulatory, you’ll be an integral part of the regulatory team leading regulatory operations and intelligence function. You’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs in alignment with regulatory strategy, along with leading the intelligence function to disseminate impact from regulatory changes across different regions.
The Experience You’ll Need
Master’s or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
7+ years of industry-related experience in a regulatory publishing function.
5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo).
Experience with setting up regulatory intelligence functions and tools is a must.
Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
Experience interacting with health authorities for operational systems is preferred.
Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
Critical thinker with excellent attention to detail.
Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
Experience in project management is a plus.
Working Location & Compensation This is an office-based, hybrid role in Salt Lake City / New York City. Employees are expected to work in the office at least 50% of the time.
Based on the skill and level of experience required for this role, the estimated current annual base range is
$175,400 - $206,400 (USD) . You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
The Values We Hope You Share
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Learn more at www.Recursion.com, or connect on LinkedIn.
Equal Opportunity Employer Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Note Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. Any resume submitted by an agency without a signed agreement will automatically become the property of Recursion.
#J-18808-Ljbffr