Regulatory Operations Associate

Sorrento Therapeutics San Diego , CA 92140

Posted 2 months ago

ABOUT US

Sorrento Therapeutics Inc. is a fast growing, clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its' extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB library"), clinical stage immuno-cellular therapies ("CAR-T"), intracellular targeting antibodies ("iTAbs"), antibody-drug conjugates ("ADC"), and clinical stage oncolytic virus ("Sephrevir").

We attract smart people who play well with others. We're small enough for your ideas to make a big impact, and large enough to offer you opportunities to grow professionally at any stage of your career.

If you're a quick learner, enjoy working in the biotech industry, and share our mission of providing ground-breaking impact to medicine, each other, and our patients, Sorrento Therapeutics is the place for you!

WHAT YOU'LL DO

We are seeking a highly motivated individual for the role of Regulatory Operations Associate. As a member of the Regulatory Affairs team, this position electronically prepares documentation that is complete, accurate, on time, and electronically functional.

The Associate will publish moderately complex, non-routine reports such as technical, nonclinical, and clinical reports and assist with submissions, including INDs, NDAs, BLAs, supplements and amendments under supervision. Responsibilities also include archiving regulatory submissions and managing Veeva Vault.

YOUR DAY-TO-DAY WORK INCLUDES

  • Performs routine general formatting, template adherence, version control, and routine document processing activities associated with the preparation of submission-standard regulatory documents for electronic submissions.

  • Participates in the electronic compilation and publishing of routine documents and reports using eCTD publishing tools.

  • Be able to identify basic issues.

  • Utilizes systems and tools for electronic document capture, generation, manipulation, scanning, and QC.

  • Ensures final document components are electronically archived.

  • May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.

  • Quality control review and edit documents.

QUALIFICATIONS

  • BS degree with strong scientific knowledge and technical background.

  • Requires a high degree of focus.

  • Must have a strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.

  • Must be able to master new technical skills and apply them to projects as the industry and the company evolves.

  • Must have good computer skills.

  • A good understanding of regulatory procedures, filing requirements and publishing is preferred.

WHAT YOU'LL LIKE ABOUT US

  • Innovative. You'll be on the leading edge of immunotherapies for the treatment of cancer.

  • Synergetic. You'll enjoy our ever changing, but collaborative company culture.

  • Rest and Relaxation. Three (3) weeks paid time off, 10 paid holidays, on-site gym.

  • Benefits. Medical with HMO, PPO, HSA and FSA options, dental/vision, and stock options.

  • Prepare for the Future. 401(k) with company match

If this sounds like the right career to fit your personality and interests, we're looking forward to meeting you.

NO RELOCATIONS

Principals only. Recruiters, please don't contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer


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Regulatory Operations Associate

Sorrento Therapeutics