Bachelor's degree in a scientific discipline or equivalent with relevant experience in Regulatory Affairs Labeling or equivalent in a highly regulated environment.
Extensive knowledge of CCDS, US and EU labeling requirements, including Rx-to-OTC switch, and ability to read and interpret HA regulations and SOPs.
Proven leadership in regulatory strategy and labeling, with experience leading cross-functional teams (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC) and preparing MAH responses.
Strong communication, interpersonal, organizational, and project management skills with the ability to coordinate across all levels of the company and present to senior management.
Requirements:
Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products to obtain company and/or agency approvals.
Coordinate end-to-end labeling process, including preparation of labeling components for submissions to regulatory agencies, participation in negotiations with agencies resulting in approvals or updates, and release of labeling for use throughout the company.
Lead a multidisciplinary labeling working group and provide labeling strategy proposals across functions (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC).
Provide oversight and strategic guidance on complex labeling projects, lead meetings, negotiate and build consensus, and present labeling strategy to senior management; ensure timely implementation and alignment with EU regulations and guidelines.
Job description
Responsibilities:
Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products assigned to obtain 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.
Strong knowledge and experience of Rx to OTC switch requirements.
Provides oversight for team and provides strategic guidance on complex labeling projects.
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.
Anticipates any hurdles in implementation and acts to minimize them.
Demonstrated knowledge and understanding of regulatory requirements for the CCDS, US and EU and local labeling implementation and the dynamics of Labeling Team purpose and objectives.
Knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products
Ability to read and interpret HA regulations and guidance, and underlying SOPs
Proven ability to lead regulatory strategy into labeling strategy.
Strong ability to lead meetings and propose labeling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
Lead a multidisciplinary labeling working group and provide labeling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC…)
Proficient in presenting to senior management when required.
Highly detail oriented, strong analytical and organized skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Must be able to construct a Company Response (MAH response) for health authority questions related to labeling.
Be an active member of Response Teams within procedures such as European Arbitration/referrals, or work-sharing, PRAC questions (signal detection…)
Extensive knowledge of EU regulations; be up to date with EU guidance's/regulations and inform management and team of changes.
Provide periodic training to the labeling team on EU regulations.
Experience:
Bachelor's degree, in scientific discipline, or relevant/equivalent with relevant years of experience in Regulatory Affairs Labeling or equivalent in highly regulated environment.
