Senior Manager Regulatory Affairs

Barrington James; Boston (MA); Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Pension plan

Child care support

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Student loan assistance

Job summary

A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates should have over 8 years of experience in regulatory affairs and a relevant degree. This position offers a competitive salary and various benefits including medical insurance and a pension plan.

Qualifications

• 8+ years of experience in regulatory affairs within the life sciences industry.
• Strong knowledge of regulatory guidelines.
• Experience with global submissions and IND maintenance.

Responsibilities

• Lead preparation and submission of CTAs to regulatory authorities.
• Monitor regulatory timelines for IND compliance.
• Manage health authority meetings and inquiries.

Skills

Regulatory affairs

Clinical trial regulations

Submission management

Multitasking

Education

Bachelor's degree in life sciences or relevant field

Job description

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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