Associate Director Regulatory Affairs Labeling

작업 내용

Purpose Of The Position

Lead global efforts for the preparation, review, approval and maintenance of drug labelling, including but not limited to, Company Core Data Sheet, prescribing information, patient information and other labelling components for development projects, as well as life-cycle management.

This position can be located in US or EU.

Key Accountabilities/Responsibilities

• Manages the development, review, approval, and maintenance of labeling for products across the portfolio
• Leads a cross-functional labelling team and manages labeling projects supporting CCDS, USPI, EU SmPC, and other labeling efforts
• Participates in and facilitates the development of the labeling objectives for projects in early development to ensure objective creation of future labelling and assists project teams in aligning labelling considerations and project development strategies
• Assist in the creation and maintenance of labeling SOPs and/or work instructions
• Works with vendors and supports creation of submission ready labeling documents including SPL and packaging artworks
• Maintains and tracks labeling documents and labelling change control activities
• Monitors worldwide regulations and guidance changes pertaining to labeling and advises management and project teams of their impact on development activities
  

Desired Skills And Experience

• Detailed knowledge of regulatory requirements pertaining to labelling requirements for marketing authorization applications globally for development projects as well as for existing products
• Good organizational skills and strong strong ability to network and coordinate discussions across all levels and functions of the company to reach resolution on labeling topics
• Detail oriented and well organized
• Good oral and written English language skills
• Active listening, understanding constraints from other discipline
• Critical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problems
• Active learning: understanding the implications of new information for both current and future problem-solving and decision-making
• Analytical skills: decision taking based on facts and figures rather than on assumptions
• Experience with electronic tools such as Adobe Acrobat Pro, and systems (e.g. Electronic Document Management System)
• Team player who seeks to help and learn from colleagues
• High learning attitude and adaptability
• At least Bachelor’s Degree
• At least 5 years pharmaceutical or industry related experience including at least 3 years in a pharmaceutical labelling related role
  

Offer

• A competitive salary package with benefits
• A work environment in a human-sized, dynamic, rapidly growing biotech company
  

Job Info

• Type: Full time
• Location: Gent