Senior GRA Labeling Specialist

• →Lead Labeling Strategy, prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products (including line extensions, dosage form, etc..) 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 marketed and LCM products (including complex update, line extensions).…
• →Support cross-functional teams as an experienced labeling expert (LWG and GRT) and contribute to the global regulatory strategy and to the preparation of labeling components of submission dossiers or responses to Health Authorities…
• →Support cross-functional teams as an experienced labeling expert (LWG and GRT) and contribute to the global regulatory strategy and to the preparation of labeling components of submission dossiers or responses to Health Authorities…
• →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.
• →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 in implementation, informs manager and acts to minimize them
• →Coordinate, create and be proficient in presenting labeling proposals to Senior Executive Management via Labeling Review Committee.…
• →Assess relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals.
• →Perform labeling competitive/comparator analysis to provide insights
• →Meet established submission timelines and quality standard for labeling deliverables.
• →Contribution to Transversal or process improvement projects/workstreams across the labeling portfolio

• Experience: Knowledge of the principles and concepts of Labeling (including generics, authorized generics, private labels, device/combination products) and the dynamics of Labeling Team purpose and objectives.
• Demonstrated knowledge of labeling requirements for drugs (CCDS EU, US); organizational and networking skills; and ability to coordinate discussions across multi-functional groups and teams (LWG, GRT,) to reach resolution on labeling topics.
• Ability to read and interpret HA regulations and guidance, and relevant company SOPs.
• Strong 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.
• Ability to lead labeling strategy connecting to regulatory strategy
• Ability to work autonomously for most tasks but needs oversight on more complex topics (occasional)
• Defined experience requirement: 10–12 years of relevant experience demonstrating advanced capability.
• Exposure to working with Regulatory Affairs, Pharmacovigilance, Medical Affairs, or clinical development
• Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc…)
• Must be able to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling.
• Soft skills: Excellent written and verbal communication skills, networking skills.
• Situational awareness and leadership skills, 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.
• Highly detail oriented, strong analytical and organization skills, project management skills, self-starter, l, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
• Technical skills: Ability to build/learn scientific knowledge (e.g. statistics, disease area) to work across therapeutic areas. Ability to search for public data on labeling elements (enabling digital capabilities)
• Education: Bachelor’s degree, in scientific discipline, or relevant/equivalent with 5 years of experience in Regulatory Affairs (including 2 years direct Labeling experience) or equivalent in highly regulated environment
• Languages: Fluent business English.

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