Sr. Regulatory Affairs Specialist

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr. Regulatory Affairs Specialist in the United States.

This role provides a pivotal opportunity to support global regulatory strategies and ensure compliance across multiple regions, including EMEA, LATAM, and APAC. You will coordinate, author, and review regulatory submissions, working closely with cross-functional teams in clinical, manufacturing, and research areas. The position requires staying current with international regulations and guidelines, assessing their impact, and providing actionable recommendations. You will contribute to regulatory strategy execution, maintain accurate documentation, and act as a key liaison across projects to ensure timelines and quality standards are met. This is a high-visibility role ideal for professionals who thrive in a fast-paced, detail-oriented, and collaborative environment, with the chance to make a meaningful impact on global health outcomes.

Accountabilities:

Coordinate, prepare, and submit regulatory documents for multiple international regions, ensuring compliance with local requirements
Review documentation from clinical, pre-clinical, research, development, and manufacturing functions for consistency with regulatory standards
Maintain up-to-date knowledge of global regulatory requirements and assess the impact of changes on assigned projects
Support the development and execution of regulatory strategies in collaboration with senior Regulatory Affairs personnel
Participate in cross-functional project teams, integrating regulatory considerations into project planning and execution
Maintain accurate and organized regulatory records, including submission archives and correspondence with agencies
Independently manage routine assignments while following guidance on complex or new tasks

Requirements:

Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, or related field)
Minimum of 5 years of regulatory affairs experience in biotechnology, pharmaceutical, or medical device industries
Proven ability to manage multiple priorities and meet deadlines in a fast-paced environment
Strong written and verbal communication skills, with attention to interpersonal collaboration
Highly detail-oriented and committed to accuracy and quality in regulatory documentation
Effective time management, organizational skills, and ability to take initiative and work independently

Benefits:

Competitive base salary: $150,000 – $165,000 annually
Comprehensive medical, dental, and vision coverage, including domestic partner benefits
Paid maternity and paternity leave
Flexible spending accounts for healthcare and dependent care
Life and accidental death insurance, short- and long-term disability coverage
401(k) retirement plan with company match and RSUs
Employee Assistance Program (EAP), legal and financial services, health club discounts, and tuition reimbursement

Why Apply Through Jobgether?

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.

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Sr. Regulatory Affairs Specialist

Requirements:

Benefits:

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