Regulatory Affairs Manager

Thousand Oaks, California | Contract

Post Date: 12/10/2015 Job ID: 1222 Industry: Quality and Regulatory Affairs

TOP 3 SKILL SETS:

Regulatory (clinical) experience; marketing application experience; global experience

 

DAY TO DAY RESPONSIBILITIES:

Leading the preparation of marketing application documents; working with the cross-functional team on reaching resolutions to issues; providing regulatory guidance; ensuring that regulatory deliverables are met in accord with planned timelines and with high quality

 

Job Summary:

Support development and execution of regulatory strategies, plans, and marketing applications for products.

 

Key Activities:

• Under the direction of the Regulatory Affairs Director, support the development, communication, and implementation of global regulatory strategies in support of the goals and product portfolio execution

• Represent Global Regulatory Affairs on cross-functional development teams

• Support development and execution of global clinical/non-clinical development strategies, including regulatory review of investigator’ s brochures, clinical study reports, and related regulatory documents required to support product development and registration

• Support development of high quality regulatory documents (CTAs, Marketing Applications, and Responses to Health Authority questions) with the focus on clinical/nonclinical aspects

• Support development of global product labels and core data sheets

• Support the planning and execution of Health Agency meetings, including generation and submission of briefing books and meeting preparations

• Collaborate and effectively communicate with partners and affiliates as required to ensure implementation of global regulatory strategies

• Provide regulatory risk assessment

Skills

  • Regulatory knowledge of global regulations
  • Regulatory submissions experience
  • Understanding of drug development
  • Previous interaction with regulatory agency representatives

 

Competencies and Skills

  • Strong oral and written communication skills
  • Ability to understand and communicate scientific and clinical information
  • Ability to anticipate and prevent potential issues
  • Ability to communicate regulatory strategies and requirements
  • Ability to provide direction and support for team members
  • Planning and organizational skills

 

Education and Experience

Doctorate degree OR Master’s degree and 3 years of regulatory experience OR Bachelor’s degree and 5 years of regulatory experience OR Associate’s degree and 10 years of regulatory experience OR High school diploma / GED and 12 years of regulatory and/or regulatory experience

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