Regulatory Affairs Senior Associate — Global Submissions & Strategy

PepGen; Boston (MA); On-site; USD 106,000 - 130,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

401(k) plan

Student loan repayment

Job summary

A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative therapeutics in neuromuscular conditions. Candidates should have a bachelor's degree in a scientific discipline, 2+ years in the pharma/biotech field, and knowledge of FDA regulations. The position offers a salary range between $106,000 to $130,000 along with a comprehensive benefits package, including a discretionary bonus and health insurance.

Qualifications

• 2+ years in the pharmaceutical/biotech industry.
• Excellent written and verbal communication skills.
• Must be willing to travel for occasional meetings.

Responsibilities

• Assist Regulatory Leads to support regulatory activities.
• Work with business partners and CROs to coordinate submissions.
• Create and maintain regulatory documents and communications.
• Contribute to clinical trial activities in line with GCP standards.

Skills

Knowledge of FDA regulations

Interpersonal skills

Ability to communicate scientific information

Regulatory submission processes

Collaboration skills

Education

Bachelor’s degree in a scientific discipline

Relevant advanced degree (e.g., MS, PharmD)

Tools

Veeva RIM

Job description

A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative therapeutics in neuromuscular conditions. Candidates should have a bachelor's degree in a scientific discipline, 2+ years in the pharma/biotech field, and knowledge of FDA regulations. The position offers a salary range between $106,000 to $130,000 along with a comprehensive benefits package, including a discretionary bonus and health insurance.