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Regulatory Expert (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Sales, Support

Projektbeschreibung

REFERENZNUMMER:

318333/11

IHRE AUFGABEN:

-Ensure regulatory filing compliance as a basis to support the business for APIs manufactured at the client's site
-Manage Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Coordination and prepare for new submissions, regular updates, variations, renewals
-Customer communication (prior and after submission of regulatory filings and/or filing updates); collaboration with customers to develop and align regulatory filing strategies and implementation plans
-Perform regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawals
-Coordination and preparation of responses to deficiency letters or authority requests or of responses to customer requests related to filings and/or other regulatory/technical questions or questionnaires
-Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.
-Regulatory assessments of change requests and development of regulatory implementation plan; provide regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
-Regulatory assessment of major non-conformances and regulatory support for inspections and audits
-Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications and ensure regulatory filing compliance and continued lifecycle management
-Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities for products manufactured in Schaffhausen

IHRE QUALIFIKATIONEN:

-Bachelor's degree with profound relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with in-depth experience
-Regulatory CMC or CMC experience is preferred and basic knowledge of regulatory requirements is required
-A working knowledge of global HA laws, regulations, and guidance is required
-Experience in developing regulatory strategies and an understanding of product development is beneficial
-Solid understanding of relevant chemistry processes and drug development experience is preferred
-A demonstrated ability to communicate regulatory requirements
-Excellent interpersonal, teamwork and verbal/written communication skills
-Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously
-Ability to communicate cross-functionally and cross-company and ability to present and defend regulatory strategy and opinion to project teams
-Business fluent in English, German skills are beneficial

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager

Projektdetails

  • Einsatzort:

    Schaffhausen, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Marketing/Vertrieb, Sonstiges

  • Skills:

    sales, support

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland