Regulatory Affairs Senior Associate

Role overview

This opportunity is being shared on behalf of a partner employer, which will handle all applications and subsequent hiring steps. The role is for a Regulatory Affairs Senior Associate located in the United States.

You will work in a tightly regulated, science-led setting that supports the advancement and approval of innovative treatments for patients facing serious and life-threatening illnesses. The position centers on preparing, coordinating, and submitting essential regulatory materials that enable clinical development and product approval. In collaboration with senior regulatory leaders, you will help maintain alignment with U.S. FDA expectations while also supporting the execution of global regulatory plans.

This position blends regulatory operations, document control, and coordination across multiple functions and regions. It also includes opportunities to improve processes, strengthen quality standards, and contribute to consistency across regulatory deliverables. The work is highly mission-oriented, with accuracy, scientific discipline, and teamwork directly influencing patient access to meaningful therapies.

Key responsibilities

• Assist U.S. regulatory leaders with assembling and submitting major regulatory filings, including INDs, BLAs, and NDAs.
• Help prepare, update, and manage regulatory records such as annual reports, amendments, and communication with agencies.
• Maintain organized archiving practices, preserve regulatory history files, and support document management systems for products.
• Research regulatory topics and contribute to updates for Global Regulatory Strategic Plans.
• Gather cross-functional inputs and supporting materials needed for submissions and agency interactions.
• Support FDA communication workflows, including responses to questions and other regulatory correspondence.
• Take part in global regulatory working groups and help with meeting setup, agendas, and outcome tracking.
• Carry out quality reviews on submission materials, including briefing packages and related components.
• Prepare standard regulatory documents, forms, and cross-reference letters for clinical and investigator-initiated studies.
• Support ongoing improvement efforts such as template creation, standard enhancement, and process optimization.

Requirements

• A bachelor’s degree plus at least 2 years of experience in regulatory work or pharmaceutical industry roles, or an equivalent mix of education and experience.
• Solid knowledge of regulatory affairs processes, preferably in biotech, pharma, or another highly regulated healthcare environment.
• Background supporting regulatory submissions or documentation for the FDA or comparable health authorities.
• Working familiarity with IND, BLA, and NDA procedures, or similar regulatory pathways.
• Strong eye for detail and the ability to manage complex documentation while meeting compliance expectations.
• Well-developed organizational skills and the ability to juggle multiple priorities in a deadline-focused environment.
• Clear written and spoken communication skills for regulatory documents and teamwork across functions.
• Ability to collaborate effectively with global teams spanning regulatory, clinical, and quality disciplines.
• Experience using regulatory document management systems is considered an advantage.
• A proactive approach and willingness to support continuous improvement and operational excellence efforts.

Benefits

• Annual pay range of $83,974.90 to $113,613.10, depending on experience and qualifications.
• Health coverage that includes medical, dental, and vision insurance.
• Retirement and savings plans that include employer contributions.
• Annual bonus opportunity plus long-term incentive potential.
• Flexible work arrangements where business needs allow.
• Paid leave, holiday programs, and well-being initiatives.
• Life insurance and disability coverage.
• Learning, training, and career growth opportunities in a global organization.
• An inclusive, collaborative culture centered on scientific progress and patient impact.

Additional information

The hiring process uses an AI-supported matching approach to help review applications quickly and consistently against the role’s core criteria. Applications that best align with the requirements are shortlisted and shared with the hiring company, while the employer’s internal team manages interviews, assessments, and final decisions.

By applying, candidates acknowledge that their personal data may be processed to assess candidacy and shared with the hiring employer under applicable data protection principles, including legitimate interest and pre-contractual measures. Applicants may exercise rights such as access, correction, deletion, and objection.

AI tools may also be used to assist with parts of the recruitment workflow, such as resume review, application analysis, and identifying potential inconsistencies or verification signals. These tools support the recruiting team and do not replace human judgment; final hiring decisions are made by people.