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Job Details

Sr. Director Global Regulatory Affairs - Medical Device, Germany

Company: Barrington James Clinical
Location:
Reference: CRBG - SRDEVDIR
Closing Date: 04 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

For more information, please contact Carlos Biggemann on +44(0)1293 776644 or email cbiggemann@barringtonjames.com

Requirements:

Main Purpose of Job:

The Sr. Director Global RA is accountable for the development and execution of global regulatory strategies and ensures that all regulatory activities performed under responsibility of HSO comply with the applicable regulations, and that product approvals are obtained and maintained in a timely and compliant manner in accordance with the overall submission planning.

Key Duties & Responsibilities:

  • A leader of the global regulatory team; this includes accurate budgeting, outstanding resource management, and effective cross-functional and cross-cultural communication and collaboration.
  • Development regulatory strategies for product approval and organizational development
  • Ensures timely approval of products or product/process changes in close collaboration with internal stakeholders within HSO.
  • Owner of the overall Global Submission Plan and accountable for ensuring cross-functional alignment in planning and execution.
  • Responsible for adequate and effective relationship management with regulators across the globe, as well as with regional teams, including operations, R&D, GHQ, and suppliers/distributors.
  • Supports senior management in development of commercial and operational strategies by advising on regulatory risks and opportunities for different options
  • Represents HSO in relevant global regulatory industry working groups or committees where deemed appropriate.

Essential Experience/Skills:

  •  Bachelor degree in a relevant discipline required
  •  10-15 years of experience in leading regulatory teams in an international organization. Needs to have indepth knowledge of the regulatory systems in EMEA and in either USA or Asia for high-risk products.
  •  Staffing skills, strong leadership skills, people skills, project management skills (both written and oral), budgeting skills and analytical skills that demonstrate the ability to recognize when a system or staff adjustments are needed.
  •  Proficient in process mapping, flowcharting, database systems, Excel spreadsheet, and Microsoft Office.
  •  Able to speak and write in English. Able to work within a fluid and dynamic international environment.

Apply for this job: Sr. Director Global Regulatory Affairs - Medical Device, Germany

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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