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Regulatory Affairs Associate Manager ( Pharma)

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Marketing

Projektbeschreibung

Keywords: [REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, INTERNATIONAL HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD] Title: Regulatory Affairs Associate Manager Role: Reporting to the Associate Director of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and contribute to much of the overall strategy. This is an extremely exciting opportunity in Florida offering a competitive salary as well as generous benefits. The position has strong focus on domestic submissions, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas. Responsibilities: -Take lead roles in pre-IND meetings and FDA conference calls - Contribute actively to NDA preparation -Organize and maintain reporting schedules for regulatory applications -Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals. - Respond to queries from FDA associated with NDA submissions - Independently review and provide feedback to the promotional review committee related to promotional marketing items. - Provide strategic regulatory support to all functional groups in alliance projects with contract manufacturers. -Represent RA on various product teams - Create, organize and manage the preparation of all types of FDA submissions Requirements: -Minimum of BS degree, ideally an MS or advanced degree in related field -At least 5 years of experience specifically in regulatory affairs -Experience reviewing outgoing FDA correspondences -Experience with INDs, NDAs, BLAs, and other regulatory submissions -Prior experience interacting with the FDA -Knowledge of eCTD publishing software preferred -A strong analytic background

To find out more about Real please visit www.realstaffing.com [1]

Links:
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[1] http://www.realstaffing.com

Projektdetails

  • Einsatzort:

    Boston, Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland