Remote Senior Regulatory Affairs Lead — Global Phase 3

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

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.