Senior Associate/Strategist - EMEA Non-OTC, RA

Responsibilities:

• Work with the regional RA team to prepare documents for the registration of OTC drugs and cosmetic products in non-EU countries.


• Provide regulatory support for select projects such as artwork maintenance and artwork support for legal department and other special projects on an as needed basis using a variety of systems internally


• Preparation and compilation of regulatory documentation for the registration and renewal of OTC drugs and cosmetic products for EMEA and local pool Support product registration in all EMEA regions including Nordics and Northern Cluster


• Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing


• Work with Kenvue regional Skin Health & Essential Health regulatory team and/or Provider Project Manager to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.


• Creation of regulatory documents, e.g., ingredient list, regulatory clearance


• Manage all EU and UK cosmetics notifications


• Regulatory review of product specification and labeling


• Support Claim Table and MasterText creation 


• Regulatory review of raw materials


• Regulatory review of materials change


• Regulatory review of formula composition


• Work with Kenvue cross functional partners to provide regulatory inputs for documents


• Regulatory review of product information file


• Prepare registration dossiers using regional data and liaising with manufacturing sites


• Support Kenvue local market contacts in their registration procedure as well as retrieving documents from APRs/GCCs


• Manage all cosmetic and femcare GCCs


• Complete market impact assessments


• Portfolio survey (where used of ingredients)

Deliverables:

• Provision of weekly updates (at a minimum) to relevant Kenvue colleagues or Provider Project Manager


• Training off-shore colleagues with respect to raw material and formulation review and approval as well as ingredient list generation


• Ensuring that regulatory standards and timelines are met


• Creation and update of working practices for processes used between Outsource partner and North America


• Regulatory Affairs for Consumer products, using lessons learned approach


• Planning and tracking the status of ongoing regulatory projects


• Ensure that standards and timelines are met


• Use of regulatory database (RegPoint) and IT tools (GSS, CAPRI, Concerto, ArtWorks, Veracity etc.)


• Create and update working practices for processes used between Outsource partner and EMEA


• Regulatory Affairs, using lessons learned approach


• Plan and track resource levels required and used for regulatory support requested.

Experience/Qualifications: 

• Minimum B.S. Chemistry, Biology, or related fields


• Minimum of two years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations