Sr. Regulatory Affairs Specialist

Summary & Scope of Position:

Coordinate and prepare documents for submissions to regulatory agencies worldwide, as appropriate by project.

Primary Responsibilities:

• Coordinate and prepare regulatory submissions for EMEA, LATAM, and APAC regions, including planning, authoring, and reviewing submission documents. Interface cross-functionally to obtain required components and ensure submissions meet applicable regulatory requirements and timelines.
• Review submission-related documentation from clinical, pre-clinical, research, development, and manufacturing functions to ensure consistency with regulatory filings and compliance with applicable regulations.
• Maintain current knowledge of EU and international regulatory requirements, guidelines, and trends. Assess the impact of regulatory changes on assigned projects and provide recommendations to regulatory and cross-functional teams.
• Support and contribute to the development and execution of regulatory strategies in collaboration with senior Regulatory Affairs personnel.
• Participate in and/or represent Regulatory Affairs on cross-functional project teams, ensuring regulatory considerations are appropriately integrated into project plans.
• Maintain accurate and up-to-date regulatory records and documentation, including submission archives and agency correspondence.
• Work independently on routine assignments, with general guidance provided for new or complex tasks.
• Perform other related duties as assigned.

Qualifications/Requirements/Skills: 

• Bachelor’s degree in a related scientific discipline with a minimum of 5 years regulatory experience in a biotechnology, pharmaceutical, or medical device company.
• Proven ability to work effectively in a fast-paced environment, managing multiple competing priorities and deadlines.
• Demonstrated ability to work independently, take initiative, and drive tasks to completion within established timelines.
• Strong communication skills, including interpersonal, written, verbal, and active listening abilities.
• Effective time management skills, with the ability to plan, prioritize, and manage multiple tasks and schedules.
• Highly detail-oriented with a strong focus on accuracy and quality.

 

We understand that our people are essential to our success.  This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position in the selected city is $150,000-165,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.