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International Regulatory Affairs Leader- based in Germany, UK or Netherlands job in Höchst im Odenwald at RBW Consulting

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International Regulatory Affairs Leader- based in Germany, UK or Netherlands at RBW Consulting

International Regulatory Affairs Leader- based in Germany, UK or Netherlands

RBW Consulting Höchst im Odenwald, DE Full Time
Required languages: German
Apply on company site

RBW is representing a performance beauty company, who are focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a seasoned, technically proficient Leader of International Regulatory Affairs.


This individual should be a passionate and motivated person who can thrive in a fast-paced, innovative environment to help develop and drive the success of regulatory affairs outside the US. If you are looking for an opportunity to grow your knowledge and abilities in a unique environment, then look no further!


This role is completely remote, working from home in either Germany, the UK or the Netherlands. The potential for growth in this role is huge, as my client plan to build out the Regulatory group in the EU.


Let’s talk about some of the key responsibilities of the role:

  • Responsible for development of International regulatory plans, identifying key regulatory issues, deliverables and remediation activities needed throughout the product/project lifecycle for existing Pharmaceutical/Biologic product and potential new drug/device products.
  • Responsible for the preparation, compilation, submission and submission tracking of EU, and global regulatory submissions for products (Australia, Switzerland, Russia, and South Africa).
  • Represent Regulatory Affairs on key activity and product launch teams.
  • Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.
  • Assist in determining regulatory requirements for local country registration, labeling, local representation, approval, and maintenance of existing pharmaceutical/biologics and potential new drug/device products in international markets.
  • Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and country regulatory Agency/Competent Authority investigations.
  • Work with Pharmacovigilance Team regarding complaints and compliance issues as needed to determine reporting requirements and provide regulatory assessments.
  • Establish clear priorities and bring key projects to completion on time, within budget and of significant impact to the growth of the business.
  • Effectively communicate project needs and deliverables to R&D/RA and upper management as needed.


Additional experience and skills that would be beneficial for this role include:

  • Specific experience in launching new drugs in each member state in Europe.
  • Knowledge of manufacturing processes associated with drugs, biologics, and devices.
  • Experience working with Contract Manufacturers and Outsource Suppliers of regulatory and logistics services.
  • Experience in systems, review, and approval of country-specific Advertising and Promotional materials for biologics, drugs, and devices.
  • Experience in working with regulatory documentation systems and IT systems for regulatory document maintenance.
  • Strong proven hands-on Regulatory Affairs experience and knowledge of regulatory submission requirements for global filings and country-specific compliance ( EU, UK , Australia, Russia etc.)
  • Effective planning, organizational and task management skills.
  • Ability to balance multiple projects with tight deadlines.
  • Strong attention to detail and ability to follow through.

Our client takes pride in being a company on the forefront of innovation, while being committed to conducting its business with the highest degrees of integrity, professionalism, and social responsibility. You’ll find yourself immersed in an environment that promotes respect, collaboration and team building, and offers a fantastic salary and package to boot!


Excited? What are you waiting for? Apply today, or contact [ Email address blocked ] +441273 952176 for more information.

 

Recommended Skills

  • Creativity
  • Management
  • Professional Attitude
  • Attention To Detail
  • Pharmacovigilance
  • Maintenance
Apply to this job.
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Job ID: 166eda0d3b0f