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Regulatory Affairs Manager Job

Eingestellt von Yoh

Gesuchte Skills: Marketing, Support

Projektbeschreibung

REGULATORY AFFAIRS MANAGER needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.

The Big Picture - Top Skills You Should Possess:
- 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
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- Plans and manages regulatory submissions (eg clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements.
- Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory guidance on regional regulatory mechanisms to optimize product development (eg Orphan Drug, Fast Track, compassionate use)
- Manages in the development of the regional product label by collaborating with the Regional Labeling team and Labeling Working Group as needed to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Supports regional label negotiation activities
- Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
- Communicates regulatory strategies within team (eg GRT, local affiliates)
- Works with line management to estimate the likelihood of regulatory success based on proposed strategies and communicates to GRT
- Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
- Ensure regulatory product compliance for product

What You Need to Bring to the Table:
- Doctorate degree, Master's degree and three (3) years of directly related experience, Bachelor's degree and five (5) years of directly related experience, Associate's degree and 10 years of directly related experience, or High school diploma/GED and 12 years of directly related experience
- Knowledge of national legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
- Team work
- 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

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Thousand Oaks, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh