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Associate Director Fo Regulatory Affairs

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

There is an urgent opening for a Regulatory Affairs Manager at the facility on site in theBostonarea. This role would be suitable for a candidate with a minimum of 5 years of diversified regulatory experience, and who is looking to join an exciting role which will involve.compiling, reviewing, and submitting ANDAs and subsequent amendments, supplemental applications, Annual Reports, Drug Listing

Responsibilities include:

-Act as liaison with FDA, developing and maintaining excellent agency relationships.
-Collaborate with project teams by developing US regulatory strategy/timelines a
-Assist in development projects, submissions, and FDA meetings
-Coordinate preparation of information and related activities for meetings with FDA
-Work on 75% domestic submissions for generic drug division
-Assist in organizing and maintainingIND/ BLA / ANDA submissions

Qualification and Experience

* Bachelors degree and 7+ years of regulatory experience in the biotech/pharmaceutical industry OR advanced degree and 4+ years of regulatory experience in the biotech/pharmaceutical industry

* Extended experience interacting with the FDA
* Prior success in ANDA and IND filings
* Outstanding communication skills
* Good interpersonal skills

There is an urgent opening for a Regulatory Affairs Manager at the facility on site in theBostonarea. This role would be suitable for a candidate with a minimum of 6 years of diversified regulatory experience, and who is looking to join an exciting role which will involve.compiling, reviewing, and submitting ANDAs and subsequent amendments, supplemental applications, Annual Reports, Drug Listing

Responsibilities include:

-Act as liaison with FDA, developing and maintaining excellent agency relationships.
-Collaborate with project teams by developing US regulatory strategy/timelines a
-Assist in development projects, submissions, and FDA meetings
-Coordinate preparation of information and related activities for meetings with FDA
-Work on domestic submissions for generic drug division
-Assist in organizing and maintainingIND/ BLA / ANDA submissions

Qualification and Experience
* Bachelors degree and 7+ years of regulatory experience in the biotech/pharmaceutical industry OR advanced degree and 4+ years of regulatory experience in the biotech/pharmaceutical industry

* Extended experience interacting with the FDA
* Prior success in ANDA and IND filings
* Outstanding communication skills
* Good interpersonal skills

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Boston, Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland