Regulatory Affairs Senior Associate

Regulatory Affairs Senior Associate

In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions. To assist the Global Regulatory Lead to manage GRT interactions.

Key responsibilities include:

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Appropriately archive regulatory documents and agency communications
• Collaborate with CRO's / partners to support site initiation
• Complete regulatory forms to support agency communications
• Participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing materials)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Actively support regulatory compliance

Preferred Qualifications:

• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to collaborate with team members to tackle problems and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others

Salary and Other Compensation:

The annual salary for this position is between $30.00 - 34.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance], [paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].