Regulatory Affairs Manager

    • Utrecht, Netherlands

Site Name: Netherlands - Zeist
Posted Date: Feb 6 2020
Regulatory Affairs Manager

AsRegulatoy Affairs manager, you will haveresponsibility for Regulatory Affairs in defined portfolios or activity streams within their markets/areas. This includes

  • Ensure products within scope (inc medicines, devices) can be placed on the market in line with commercial plans
  • Ensure products are maintained and meet internal and external compliance requirements
  • Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, marketing/sales within local commercial business, supply chain and quality etc. Has the ability to lead a team of regulatory professionals if required (e.g. project, back up).
  • Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK with local regulators, trade associations and other key external regulatory bodies.
  • Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.
  • Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope

Your responsibilities:

  • Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations
  • Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and mitigation plans plans that are robust and aligned with business needs
  • Actively contribute to high performing teams, including looking for ways to improve performance. May lead cross-functional teams and regulatory professionals within local market in the context of a project etc.
  • Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK policies and strategies and negotiate outcomes
  • Manage compliance within defined portfolio/activity streams in line with GSK expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as CBG/MEB regulations). Propose solutions to identified issues and implement
  • Collaborative working together with other functions (eg., marketing, supply chain) to deliver company objectives
  • Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business
  • Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required to build knowledge and compliant utilization
  • Maintain high level of product knowledge within defined portfolio


Why you?
Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • University Degree in Life Science
  • Ideally a minimum of 5 years experience in Regulatory Affairs in a pharmaceutical industry
  • Highly proficient in both spoken and written English/ Dutch
  • Able to work effectively across all dimensions of matrix organization (effective written and verbal communication is critical to success here). Senior management interactions within local market and externally

*Li-GSK

Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Pharmaceuticals -Our Pharmaceuticals business offers a unique portfolio of medicines, including a broad range of innovative and established brands. Both globally and in the Netherlands, we are currently primarily focused on developing new medicines in the respiratory, HIV/infectious diseases, oncology and immuno-inflammation areas, while also continuously exploring other fields through discovery research. Working in our BeNeLux branch, you would be joining a driven team of over 200 people that is also well embedded within GSK's global network. For further information, please visit www.gsk.com .

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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