Summary :

The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that 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 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.

Top 3 Must Have Skill Sets :

Can-do / Solution Oriented 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 (Client is a very large organization and there will be many parties the candidate will need to engage with for project success).

Being Comfortable With Being Uncomfortable Ideal candidate will not only be able to identify problems but also identifies 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.

Requirements :

Desire to learn Regulatory Affairs CMC and global submission strategy

Strong organizational skills with attention to detail

Proficient time management skills and ability 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

Bachelor or Master degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR High school diploma / GED and 8 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical, and / or related scientific experience

Experience :

Degree in life sciences, biochemistry, or chemistry

Experience working in a lab / QA / manufacturing environment are good fits for this role

Experience in biopharmaceutical or pharmaceutical industry

Familiarity with eCTD structure

Experience in CMC, including preparation of submissions to Agencies

Proficient skills in Microsoft Office suite

Compensation :

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries :

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.