["Senior Associate - Regulatory Affairs","Senior Associate - Regulatory Affairs"]

Senior Associate - Regulatory Affairs

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.