This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Associate - Generalist in the United States.
This role is a key contributor within global regulatory operations, supporting end-to-end regulatory activities across clinical development, submissions, and post-approval lifecycle management. You will work in a highly collaborative, cross-functional environment, acting as a regulatory liaison between internal teams and external alliance partners. The position involves ensuring compliance with global regulatory requirements while supporting the preparation, tracking, and execution of critical regulatory documentation. You will contribute directly to submission readiness, regulatory strategy execution, and operational excellence across multiple programs. This is a detail-oriented and highly structured role where organization, communication, and problem-solving skills are essential. You will also participate in governance meetings and help ensure alignment across global regulatory stakeholders.
Accountabilities
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
This role is a key contributor within global regulatory operations, supporting end-to-end regulatory activities across clinical development, submissions, and post-approval lifecycle management. You will work in a highly collaborative, cross-functional environment, acting as a regulatory liaison between internal teams and external alliance partners. The position involves ensuring compliance with global regulatory requirements while supporting the preparation, tracking, and execution of critical regulatory documentation. You will contribute directly to submission readiness, regulatory strategy execution, and operational excellence across multiple programs. This is a detail-oriented and highly structured role where organization, communication, and problem-solving skills are essential. You will also participate in governance meetings and help ensure alignment across global regulatory stakeholders.
Accountabilities
- Manage regulatory archiving activities, including submission logs, correspondence tracking, indexing, and document control within RIM and EDMS systems.
- Support clinical regulatory operations, including maintenance of Form FDA 1572 documentation, waiver requests, and GLP-related reviews.
- Assist in the preparation and assembly of regulatory submissions, including FDA forms, cover letters, metadata, and structured electronic submission packages.
- Coordinate submission workflows, ensuring timely review, approval, and delivery through established regulatory publishing processes.
- Contribute to clinical and global regulatory team meetings by preparing materials, tracking actions, and providing regulatory updates.
- Support drafting and review of regulatory documents such as IND submissions, briefing packages, meeting requests, and designation applications.
- Ensure compliance with post-approval regulatory obligations, including safety reports, annual reports, and benefit-risk assessments.
- Maintain tracking systems to ensure deadlines and regulatory commitments are met across development and marketed products.
- Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred.
- 3+ years of experience in regulatory affairs within the pharmaceutical, biotech, or CRO industry.
- Strong knowledge of global regulatory processes, including clinical, submission, and post-approval requirements.
- Experience with regulatory information management (RIM) systems and electronic document management systems (EDMS).
- Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Strong written and verbal communication skills, with the ability to work across global and cross-functional teams.
- Solid analytical and problem-solving abilities with attention to detail and regulatory accuracy.
- Project coordination or regulatory operations experience is highly preferred.
- Ability to collaborate effectively in a client-facing, partnership-driven environment.
- Competitive compensation aligned with experience and market standards.
- Comprehensive healthcare coverage including medical, dental, and vision insurance.
- Paid time off and holiday benefits to support work-life balance.
- Retirement savings plans and financial security programs.
- Professional development opportunities within a global clinical research organization.
- Fully remote work flexibility within eligible U.S. time zones (Eastern or Central preferred).
- Exposure to global regulatory programs and cross-functional international teams.
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.