Job Details
Posted 29 July, 2026
Job Id: 629653
Senior Associate – Regulatory Affairs, Oncology
Job Description
Target PR Range: 22-32/hr DOE
Senior Associate – Regulatory Affairs, Oncology
What you will do
In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
* To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
* To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
* To assist the Global Regulatory Lead to manage GRT interactions
Key responsibilities include:
* Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
* Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
* Create and maintain product regulatory information and history documents through systems
* Appropriately archive regulatory documents and agency communications
* Collaborate with CROs / partners to support site initiation
* Complete regulatory forms to support agency communications
* Participate in GRT to support execution of regulatory strategy
* Coordinate QC of regulatory documentation (e.g. briefing materials)
* Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
* Assist in template development and maintenance
* Respond to specific requests from and communicate relevant issues to GRT
* Actively support regulatory compliance
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.
Basic Qualifications:
Masters degree
Or
Bachelors degree and 2 years of Regulatory Affairs experience
Or
Associates degree and 6 years of Regulatory Affairs experience
Or
High school diploma / GED and 8 years of Regulatory Affairs experience
Preferred Qualifications:
* Strong communication skills – both oral and written
* Ability to understand and communicate scientific/clinical information
* Ability to collaborate with team members to tackle problems and develop a course of action
* Cultural awareness and sensitivity to achieve global results
* Planning and organizing abilities
* Able to prioritize and balance multiple activities
* Ability to deal with ambiguity
* Ability to influence others
*CO/NYC candidates might not be considered
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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