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Form of workSummary
Opportunity to join an award winning Pharma. With several decades in the industry, and new acquisitions, this company can offer security and opportunities for growth.
Job Description
Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables. Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
Responsibilities and Deliverables:
Regulatory review and approval of product labelling for Cosmetics and other non-OTC classes per the company portfolio in mainly UK & Ireland
Regulatory review and approval and advertising or promotional copy for Cosmetics and other non-OTC classes mainly in UK & Ireland
Support the Regulatory team with specific tasks per the needs of the department, which may include claims tracker updates, databases, compliance tasks
Work with the regulatory team to develop project implementation plans and manage resource planning to ensure on time completion of projects and tasks
Project management and implementation of regulatory changes to company assets (product label and promotional materials)
Work with cross functional partners to drive regulatory strategy and implementation
Regulatory review and approval of key documents before product ap
Complete market impact assessments
Portfolio survey (where used of ingredients)
Experience/Qualifications:
Minimum B.S. Chemistry, Biology, or related fields
Significant experience in Cosmetic Regulatory affairs mainly with promotional material and artwork review/approval at all stages of life cycle management, with demonstrated accountability of managing multiple brands.
Well versed with UK ASA, CAP, BCAP Guidance for Advertising, proven record of successful project management of dossiers with ClearCast
Strong knowledge and application of the UK & EU Cosmetic Product Regulation
Excellent leadership, communication, and organizational skills
Attention to detail, effective in written and oral communication
Works independently to plan, conduct, and manage regulatory projects to meet department and company objectives
Responsible for identifying, implementing and managing key RA Departmental projects and/or strategies based on both short- and long-term RA Department objectives.
This Role is an urgent need. So, the processes for these roles are moving very quickly so if there is an interest, we will need to move fast to ensure you don’t miss out.
These positions will be snapped up, looking for individuals who are ambitious, positive and want to work in a growing and exciting team.
Do not miss out on this opening – apply below or contact Kush Obhrai at Square One Pharma
