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Sr Associate Regulatory Affairs CMC

  • Permanent
  • Anywhere

Website Donatech Corporation

Donatech Corporation

Company : Donatech Corporation

Country: United States

Location : Thousand Oaks, California

Post: Fri, 09 Sep 2022 15:43:53 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position would require the candidate to be a W2 employee of Donatech

Our company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment.. In accordance with applicable law, we will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to our company, its operations, or its staff.

Remote Role – Supporting Pacific time zone. Core hours are 7:30am-4:30pm

Would like pharma experience.

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. Contributes to the organization and preparation of regulatory submissions for new marketing applications, post-market supplements, investigational product amendments, annual reports, and renewals for specific products to meet the strategy defined by the International Regulatory CMC team

What we are looking for:

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;

Qualified to work in the U.S. without employer sponsorship;

Commitment of a 40-hour work week in Thousand Oaks, California

Experience

o Master’s degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

o OR

o Bachelor’s degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

o OR

o Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

o OR

o 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

Daily Responsibilities

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

Employee Value Proposition

You will work directly with project teams in multiple global geographical locations in support of submission execution. The projects you will be involved with will have a positive impact on key company processes that support the making of human therapeutics and the patients that use them.

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