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Actalent Regulatory Publishing Manager in Morristown, New Jersey

Seeking a Sr. Regulatory Publisher, specializing in OTC/Rx products. Great company culture, opportunities for career growth, competitive starting salary and immediate access to benefits.

Description:

MUST HAVES:

  • 5 years of experience with hands on publishing

  • Previous experience publishing documents for ANDA submissions to the FDA within a generic pharmaceutical company

  • Advance experience within regulatory affairs with use of publishing software such as eCTD, ISItoolbox

Primary responsibilities of this role include the following:

  1. Publishes US Regulatory Submissions to the Food and Drug Administration: ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc.

  2. Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.

  3. Develops and maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.

  4. Manages all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.

  5. Monitors and maintains familiarity with evolving and/or new regulatory e-submission requirements and ensures that all functional disciplines are apprised of the changes and trained accordingly.

  6. Authors, develops and/or collaborates on SOPs and Work Instructions for the Publishing and Electronic Document Management System.

  7. Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.

  8. Monitors and maintains the highest level of submission standards.

  9. Independently track and manage all correspondence between company and government agencies, including phone calls, emails, and relevant documents.

  10. Accurately update and maintain spreadsheets and databases in a timely manner.

Skills:

CMC, publish*, regulatory, ANDA, FDA

Top Skills Details:

CMC, publish*, regulatory, ANDA, FDA

Additional Skills & Qualifications:

  • Minimum of 5 years of experience within the pharmaceutical industry

  • Minimum 3-4 years of experience working within regulatory

  • Experience publishing and submitting ANDA files to the FDA within a generic pharmaceutical company

  • Previous experience using various publishing softwares

  • Strong verbal and written communication skills

• Minimum of a Bachelor’s Degree in a life science. Advanced degree preferred.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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