Senior Manager Regulatory Affairs

Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission planning, coordination, and execution across multiple regions, ensuring smooth and successful interactions with health and regulatory authorities.

Responsibilities

Lead preparation and submission, and maintenance of CTAs to regulatory/health authorities

Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance

Lead in the preparation, submission, and maintenance of CTAs to regulatory authorities

Lead the preparation and execution of health authorities meetings and questions (FDA, EMA, PMDA, etc.)

Keep track of submissions and approval status globally, providing regular updates and reports to leadership

Requirements

At least 8 years in regulatory affairs within the life science space

Bachelor's degree in life sciences or relevant field

Strong knowledge of regulatory guidelines and clinical trial regulations

Proven experience with global CTAs submissions and IND maintenance

Ability to manage multiple priorities and work in a fast-paced, dynamic environment

This role comes with a competitive base salary and benefits.

Medical insurance

Pension plan

Child care support

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Student loan assistance

Seniority level

Not Applicable

Employment type

Full-time

Job function

Science

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