Sr Associate Regulatory Affairs – CMC

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Senior Associate in Regulatory Affairs to support the Chemistry, Manufacturing, and Controls department. This role involves managing regulatory CMC projects and ensuring compliance across various phases of product development. The ideal candidate will possess strong organizational skills, a keen attention to detail, and a proactive attitude towards problem-solving. With a focus on teamwork and independent work, this position offers the opportunity to contribute significantly to regulatory submissions in a dynamic environment. If you thrive in a fast-paced setting and are eager to make an impact, this role is perfect for you.

Qualifications

• 2+ years of Regulatory experience or 4+ years with a Bachelor's degree.
• Experience in biopharmaceutical or pharmaceutical industry preferred.

Responsibilities

• Provide submission execution support across modalities and regions.
• Organize and manage regulatory CMC projects and submissions.

Skills

Organizational Skills

Time Management

Team Collaboration

Attention to Detail

Analytical Skills

Education

Master's Degree in Life Sciences or Related Field

Bachelor's Degree in Life Sciences or Related Field

Associate Degree in Life Sciences or Related Field

High School Diploma / GED

Tools

Microsoft Office Suite

Job description

Description:

Remote- any US time zone is OK

Overview

• The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development.
• Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.
• Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

What we are looking for:

• Strong organizational skills with attention to detail;
• Proficient time management skills and ability to prioritize workload;
• Ability to work both independently and as a member of a team;
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
• Qualified to work in the U.S. without employer sponsorship;

Experience
Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR High school diploma / GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience.

Preferred Qualifications

• Degree in life sciences, biochemistry, or chemistry;
• Experience in biopharmaceutical or pharmaceutical industry;
• Familiarity with eCTD structure;
• Motivated with initiative to learn quickly;
• Experience in CMC, including preparation of submissions to Agencies;
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;

Top 3 Must-Have Skill Sets

• Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude.
• Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identify possible solutions. Project end goals will be known but all the in-between steps may not be known from the start, so the candidate will need to navigate and structure the steps without being easily flustered.
• Attention to Detail – Ideal candidate will be thorough and deliver polished work product.

Daily Responsibilities

• Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development.

Pay Rate between $31 - $36/Hr on W2 based on experience.

This posting is for Contingent Worker, not an FTE.