GRA Labelling Specialist

• Prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products for company and/or agency approval.
• Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for mature/marketed products.
• Support cross-functional teams (LWG) as a labeling expert and contribute to the global regulatory strategy and to the preparation of of labeling components of submission dossiers or responses to Health Authorities?
• For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work sharing, PRAC questions (signal detection)
• Anticipates any hurdles and informs manager as appropriate
• Coordinate and create the presentation of labeling proposals to be presented to Senior Executive Management via Labeling Review Committee
• Perform labeling competitive/comparator analysis
• Meet established submission timelines and quality standard for labeling deliverables
• Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.

About you

• Experience: Knowledge of the principles and concepts of Labeling (including generics), and the dynamics of Labeling Team purpose and objectives.
• Knowledge of labeling requirements for drugs (CCDS EU, US); organizational and networking skills; and ability to coordinate discussions across a multi-functional group (LWG) to reach resolution on labeling topics.
• Ability to read and interpret HA regulations and guidances, and relevant company SOPs.
• Ability to connect regulatory strategy into labeling strategy
• Ability to work autonomously for routine tasks but needs oversight on more complex topics (as needed)
• Ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC?), provide labeling strategy proposal, negotiate, resolve conflict and build consensus.
• Must be able to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling
• Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc?)
• Soft skills: Excellent written and verbal communication skills, networking skills.
• Situational awareness, problem solving skills.
• Organizational skills, ability to manage multiple projects at short notice.
• Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
• Defined experience requirement: 6 to 9 years of relevant industry or functional experience.
• Technical skills: Highly detail oriented, strong analytical and organization skills, project management skills, self-starter, critical thinking required, ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics. Ability to build/learn scientific knowledge (e.g. statistics, disease area).Ability to search for public data on labeling elements (enabling digital capabilities)
• Education: Bachelor's degree in Lifesciences or equivalent, with 3 plus years of related work experience in Regulatory Affairs/Labeling or equivalent in highly regulatory environment
• Languages: Fluent business English.