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Entry Level or Intern Scientist / Regulatory Associate (CMC)

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Oncotelic Therapeutics, Inc. is a pharmaceutical company who specializes in TGF-beta 2 antisense for the treatment of metastatic pancreatic cancer and high-grade glioma. We are seeking an entry-level or intern Scientist / Regulatory Associate that will support the Chemistry, Manufacturing, and Controls (CMC) department of the company. This individual is someone that is an independent thinker/worker and can thrive in a fast-paced, innovative environment to help develop and drive the success of the CMC department. Only local candidates near the San Diego, Orange or Los Angeles County will be considered.

 

Key Responsibilities:

-        Assist in CMC-related submissions and manage regulatory writing and timely delivery of high-quality technical documents.

-        Interacts with colleages in other departments, and RA functions to deliver high-quality dossiers, documents, and materials in accordance with corporate and team goals.

-        Regulatory support on technical and quality activities, such as manufacturing process development, specifications, in-process controls, stability protocols, and product and compliance quality initiatives.

-        Maintain knowledge and expertise of the regulatory documentation system(s) to ensure efficiency, traceability, and compliance of regulatory CMC documents.

 

Essential Qualifications:

-        Degree in science or engineering field required.

-        Proficient skills in Microsoft Office suite, especially Word, Excel, and Powerpoint.

-        Independent thinker who is able to work as a member of a team.

-        Strong organizational skills with attention to details as well as excellent time management skills.

-        Motivation with the initiative to learn new concepts quickly.

 

Preferred Qualifications:

-        Experience in bio or pharmaceutical industry.

-        Experience in CMC, including preparation of submissions to Agencies, i.e. FDA, EMEA, etc.

 

If interested, please send your application to chsiao@oncotelic.com.

 

 

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