Bachelor's degree in a scientific discipline or equivalent with relevant years of experience in Regulatory Affairs Labeling or equivalent in a highly regulated environment.
Extensive knowledge of EU regulations, guidance, and labeling requirements (CCDS, US and EU labeling) with ability to interpret HA regulations and SOPs.
Proven ability to lead regulatory strategy and translate it into labeling strategy; experience leading cross-functional labeling teams and meetings.
Strong communication, interpersonal, organizational, and leadership skills; able to work across domestic and international teams and manage multiple stakeholders.
Requirements:
Create, prepare, and revise CCDS, US, and EU labeling for mature and life-cycle products to obtain company and/or agency approval.
Coordinate labeling review and approval across the end-to-end labeling process, including preparation of submission components, participation in labeling negotiations with agencies, and release of labeling for use throughout the company.
Lead a multidisciplinary labeling working group and provide labeling strategy proposals involving Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, Preclinical, and CMC.
Provide training on EU regulations to the labeling team and act as an active member of response teams for procedures such as European arbitration/referrals, PRAC questions, and cross-functional discussions to ensure regulatory compliance.
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.
