Main purpose of the job:
• Understanding of the Regional Regulatory procedure for MAs and US post approval changes, extensions, and renewals.
• Provide support within the Global Labeling function in the US and UK, promoting and creating a professional environment
• Anticipate regulatory labelling obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Support operationalise labelling activities across all products
• Act as a support for local, regional and multi-country regulatory labelling requirements.
• Support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.
• Report to the Head of Global Labelling.
Responsibilities will include but not be limited to:
• Management of drug listing and establishment information in SPL by working effectively with vendors.
• Work with manufacturing/packaging sites concerning labeling changes and implementation, and respond to e-mail queries related to activities associated with assigned projects to ensure accurate daily workflow.
• Review/Approval of final artwork.
• Provide Supply Chain and QA guidance on labeling implementation requirements.
• Prepare summary of labeling changes (including components and revision/version information) during a given reporting period for inclusion in an Annual Report.
• Provide product labeling proofreading support, as necessary.
• Ensure product labeling reporting alignment with CFR and internal requirements.
• Maintenance of distribution lists, management of documents in an electronic document management system, compliance tracking and reporting, labeling systems management.
Tools and equipment used / working environment:
The Associate, Global Labelling is expected to possess a strong working knowledge of Microsoft Office applications, document management systems,
The Associate will report to the Head of Global Labelling. This individual will be expected to routinely work in a global, multidisciplinary environment with such individuals as those within the Global Regulatory Network, the Oncology and Neuroscience Business Groups, Medicine Development Center, affiliates, partners, Legal, Commercial, and Safety.
1. Qualifications, education and language requirements:
• Bachelor’s degree or higher in Life Sciences
• Excellent written and spoken English
2. Experience Required:
• Experience in Regulatory, R&D or related area or equivalent experience within the pharmaceutical industry.
• Knowledge of global regulations, guidance documents, ICH guidelines, and demonstrated ability to apply regulatory guidelines to product labelling.
• Demonstrates a solid working knowledge of drug development
• Proven interpersonal skills; negotiating, communicating, coaching & explaining.
3. Skills and Aptitude Required:
• Experience in local and global regulatory environments and work on multiple projects.
• Be team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity- working environment.
• Able to work under pressure.
• Scientific background or familiarity with medical terminology and knowledge of FDA regulations and guidance is preferred.
• Proficiency with document comparison software, Microsoft Office, Excel, Outlook, PowerPoint, SharePoint, and Adobe Professional.
• A high level of skill in written English, including spelling, grammar and punctuation.
• Experience with proofreading
• Detail oriented ability to work independently, and meet deadlines.
Source: Job Diva – Job Listing