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Regulatory Affairs Manager II Job

Eingestellt von Yoh

Gesuchte Skills: Support, Marketing

Projektbeschreibung

Yoh has a contract opportunity for REGULATORY AFFAIRS MANAGER II to join our client in Thousand Oaks, CA

JOB RESPONSIBILITIES:

- This role will support one or more products from a regional regulatory perspective.
- As a member of the Global Regulatory Team (GRT), they will achieve the desired labeling by developing and executing regional regulatory strategies and managing effective agency interactions. The purpose of this role is:
- To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
- To ensure regulatory compliance, with a focus on patient safety
- Region Specific Activities
- US: Advises and supports promotion group regarding applicability of data for product communication in the US
- EU: Review and approve promotional and non-promotional materials for use in the region
- EM: Manage the product life cycle for individual countries per national agency requirements
- EM: Work through the regional leads to manage distributor markets
- Strategy and Execution
- Plans and manages regulatory submissions (eg clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.

JOB QUALIFICATIONS:

- Communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Understanding of regulatory activities and their touch points
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
- Competencies:
- Planning and organizing
- Managing multiple activities
- Problem solving
- Setting priorities
- Action orientated
- Working in teams
- Presentation Skills
- Written Communications
- Leadership skills
- Conflict management
- Good listening skills
- Managing and measuring work
- Negotiation skills

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Salima Hakim

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WBRSDIEGO

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Thousand Oaks, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh