Head of Regulatory Affairs

Company
AL2S3 LTD
Location
Denmark (DK)
Salary
130,000 SEK + Fantastic Pension + Benefits
Posted
06 Jan 2021
Closes
05 Feb 2021
Ref
JZFKDK
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Josh Zarembski is delighted to offer to the market a fantastic opportunity working with a niche, nordic based, pharmaceutical organisation, Their mission is to put heart, soul, and skills into making a difference for people living with severe disease.

After recent success, this company will be strengthening their Global Regulatory Affairs department, with offices in Sweden, Denmark & Norway I am are looking for a talented individual to fill the position of: Head of EU Regulatory Affairs.

As a Head of EU Regulatory Affairs, you will provide regulatory oversight for therapeutic/disease area(s), senior leadership and mentorship for PVU deployed Global Regulatory Leads (GRLs) and line manages Practice-based GRLs, regulatory science staff, labelling, advertising and promotion staff and regulatory intelligence and policy staff within the EU and MEA (EMEA) region.

Responsibilities Include:

  • Recruiting, developing, and retain highly talented and skilled regulatory scientists, labeling, advertising and promotion staff and regulatory intelligence and policy staff.
  • Providing regulatory leadership specific to the US therapeutic/disease area strategies to PVU leadership.
  • Ensuring regulatory resources are provided for early and late stage development and life cycle projects (in conjunction with the GRL).
  • Ensuring that regulatory therapeutic/disease area strategic options, assessments, and risks specific to the US are communicated to the PVU.
  • Achieving EMEA regulatory alignment for disease area regulatory strategy with input from PVU leadership, GRLs, and Regional Leads.
  • Awareness & application of global regulatory environment within the EMEA region (e.g. Health Authority guidance, new approvals, overall regulatory landscape).
  • Driving a culture of excellence and motivates employees to perform at their highest ability.
  • Providing a high level strategic EMEA regulatory direction and mentorship to GRLs including general regulatory strategies, regulatory strategic development plans and risk assessments, regulatory critical issue management.
  • Leading special regulatory projects/process initiatives of high complexity, ensuring global alignment.
  • Acting as an interface between PVU and EU PVO Leadership teams and GRA and build partnerships with PVU leadership and other PV Practices and Regions to ensure that strategic business goals are met through the sharing of knowledge and the provision of appropriate resources.

Experience and skills:

  • Extensive experience in the pharmaceutical industry, coupled with regulatory experience or related experience.
  • EU regulatory experience (Americas, MEA; APAC a plus) required with a proven track record of significant regulatory accomplishments.
  • Thorough understanding of drug development process and global regulatory requirements and processes.
  • Up to date knowledge of the EU regulatory environment; thorough understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide.
  • Up to date knowledge and appreciation of the science driving drug discovery & development processes and product lifecycles.
  • Demonstrated ability to make compelling scientific and/or strategic arguments to support all regulatory aspects related to the therapeutic/disease area.
  • Ability to read, interpret, evaluate and disseminate regulatory guidance and policy to ensure regulatory compliance, including ability to analyze the impact on strategic direction and operations.

Apply

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.

Josh Zarembski
AL Solutions