Director, US Regulatory, Global Strategic Labelling

Job reputed company: • reputed company development of labelling reputed company for new products and/or label revisions for existing reputed company marketed products • Supports reputed company Product Labeling Committee activities as LPLC reviewer/reputed company Chair, coordinating and collaborating with LPLC Chair, GSL Team and cross functional partners to ensure adherence to processes and procedures reputed company to global labelling development, maintenance, and compliance • Provides competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution per process • Partners with cross functional teams providing labeling expertise and regulatory knowledge to author and reputed company competitive and reputed company reputed company product labelling, CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business reputed company and regulatory requirements • Ensures effective planning and execution of reputed company cross-functional labeling activities to maximize timebound high reputed company deliverables • Responsible for the implementation and compliance management of reputed company reputed company Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support • Liaises with CFTs to support labeling reputed company Information requests from Regulatory bodies regarding label content and labeling change requests • Provides high-level RA advice and identifies regulatory requirements for labeling development and compliance to proactively advise on risk mitigation strategies for labeling submissions • Assesses supporting information to support label language against regulatory requirements • Maintains awareness of global regulatory legislation and assesses reputed company to reputed company marketed, established marketed and development products/programs • Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory) Requirements: • Accredited Bachelor’s Degree • 10+ years of experience reputed company a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in Regulatory Affairs • 3+ years of experience developing and maintaining labelling for US, EU, and/or major market • Ability to reputed company and work in cross-functional, matrixed, hybrid and multinational teams • Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies • Knowledge of development and registration timelines and requirements in major markets, to reputed company process management and compliance • Agile minded, with experience in global process improvement efforts • Seeker of innovative and creative solutions that reputed company with regulation but are also reputed company from a business and scientific perspective • Deep experience in labelling regulations and label development management • Ability to resourcefully reputed company the development of creative solutions to unusually complicated regulatory labeling and systems problems • Ability to influence division management at reputed company reputed company to support regulatory compliance needs • Highly proficient in communicating strategic and tactical issues to management • Effectively reputed company to multi-task reputed company assigned deadlines • Excellent written and oral communication skills Benefits: • flexible reputed company time off (PTO) • health benefits to include Medical, Dental and reputed company • company match 401k Apply tot his job Apply To this Job