Senior Associate - Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Associate - Regulatory Affairs based in United States.

This role provides the opportunity to support the development and delivery of innovative therapies by helping ensure regulatory strategies are executed with accuracy, quality, and compliance. As a Senior Associate in Regulatory Affairs, you will contribute to regulatory submissions, agency communications, and documentation processes that support important healthcare programs. You will collaborate with cross-functional teams across clinical, medical, commercial, and regulatory functions to advance product development initiatives. This position is ideal for a detail-oriented regulatory professional who enjoys managing complex documentation, improving processes, and contributing to impactful scientific work. You will work in a collaborative, science-driven environment where your expertise helps bring new treatments closer to patients. The role offers strong opportunities for professional growth within a global healthcare organization.

Accountabilities:: Support regulatory activities by assisting with the preparation, review, and submission of regulatory documents under the guidance of experienced regulatory leads.

Maintain regulatory documentation, including product histories, agency communications, submission records, and archival systems.

Provide support for regulatory filings such as annual reports, amendments, investigator packages, and other required documentation.

Collaborate with cross-functional teams to coordinate regulatory deliverables and ensure compliance with submission requirements.

Review regulatory plans and contribute input to operational activities supporting product development strategies.

Support health authority interaction activities and assist with preparation of regulatory materials, briefing documents, and correspondence.

Coordinate the collection, quality control, and organization of regulatory documents from internal teams, partners, and external vendors.

Participate in regulatory strategy discussions and support execution of regulatory goals within assigned programs.

Provide regulatory guidance and support to clinical, medical, commercial, and other internal stakeholders.

Contribute to process improvement initiatives, development of regulatory standards, template creation, and operational efficiency improvements.

Monitor regulatory compliance activities and communicate relevant updates, risks, or issues to appropriate teams.

Requirements:

Master’s degree required, or equivalent combination of education and regulatory experience.

Qualified candidates may also have a bachelor’s degree with 2+ years of Regulatory Affairs experience, an associate degree with 6+ years of relevant experience, or a high school diploma/GED with 8+ years of Regulatory Affairs experience.

Preferred background includes a master’s degree in biology, life sciences, health sciences, or regulatory science with a strong biological focus.

Experience working in a regulated industry, scientific environment, or clinical setting is highly valued.

Understanding of regulatory processes, documentation requirements, and compliance standards.

Strong organizational skills with the ability to manage timelines, priorities, and multiple deliverables.

Excellent written and verbal communication skills with the ability to collaborate effectively across teams.

Ability to support meetings through agenda preparation, documentation, follow-up actions, and coordination.

Detail-oriented mindset with strong problem-solving skills and the ability to work independently.

Experience contributing to process improvements, operational initiatives, or regulatory systems is preferred.

Benefits:

Competitive salary range of $83,974.90 – $113,613.10 USD per year , depending on skills, experience, qualifications, and location.

Comprehensive employee benefits package, including medical, dental, and vision coverage.

Retirement and savings plans with company contributions.

Life and disability insurance coverage.

Flexible spending accounts.

Eligibility for annual bonus programs.

Long-term incentive opportunities through stock-based rewards.

Generous paid time off programs.

Flexible work models where applicable.

Career development opportunities and support for professional growth.

Opportunity to contribute to meaningful healthcare innovations that impact patients worldwide.

How Jobgether works: 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.     #LI-CL1