Senior Associate Regulatory Affairs

Ampcus Inc; Thousand Oaks (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

An established industry player is seeking a Senior Associate in Regulatory Affairs to join their dynamic team. This role involves providing critical support to the regulatory CMC department, managing projects, and ensuring compliance across various development phases. The ideal candidate will possess strong organizational skills, a keen attention to detail, and proficiency in Microsoft Office Suite. With a commitment to a 40-hour work week, this position offers the opportunity to impact therapeutic development significantly. If you thrive in a collaborative environment and are eager to contribute to meaningful projects, this role is perfect for you.

Qualifications

• 2+ years in regulatory affairs or related field with a Master's degree.
• 4+ years of relevant experience with a Bachelor's degree.
• 6+ years of experience with an Associate degree.

Responsibilities

• Support regulatory CMC projects and manage document reviews.
• Organize and execute regulatory submissions across development phases.
• Draft agendas and minutes for project meetings.

Skills

Organizational Skills

Time Management

Team Collaboration

Microsoft Office Suite

Problem-Solving Skills

Attention to Detail

Education

Master's Degree

Bachelor's Degree

Associate Degree

High School Diploma/GED

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented team.

Job Title:

Senior Associate Regulatory Affairs

Location(s):

Thousand Oaks, CA (Remote)

Overview

The Senior Associate Regulatory Affairs (CMC) provides support to the regulatory Chemistry, Manufacturing and Controls (CMC) department across regions and phases of development. Responsibilities include organizing, managing, and executing regulatory CMC projects, formatting documents, managing data from regulatory repositories, drafting agendas and minutes, and managing document reviews.

What we are looking for:

• Strong organizational skills with attention to detail;
• Proficient in time management and workload prioritization;
• Ability to work independently and as part of a team;
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project);
• Authorized to work in the U.S. without employer sponsorship;
• Commitment to a 40-hour work week in Thousand Oaks, California.

Experience

• Master's degree with 2 years of regulatory (CMC preferred), compliance, quality, biopharmaceutical, pharmaceutical, or related scientific experience;
• Bachelor's degree with 4 years of relevant experience;
• Associate degree with 6 years of relevant experience;
• High school diploma/GED with 8 years of relevant experience.

Preferred Qualifications

• Degree in life sciences, biochemistry, or chemistry;
• Experience in the biopharmaceutical or pharmaceutical industry;
• Familiarity with eCTD structure;
• Motivated to learn quickly;
• Experience with CMC submissions to agencies;
• Proficient in Microsoft Office Suite.

Top 3 Must-Have Skill Sets

• Can-do attitude with resilience and positivity;
• Comfort with ambiguity and problem-solving skills;
• Attention to detail and thoroughness in work quality.

Daily Responsibilities

Providing submission support across modalities, regions, and development phases, directly impacting key processes in therapeutics development.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans, or individuals with disabilities.