Regulatory Affairs Manager coordinating regulatory submissions and compliance for Patient Assistance Programs in Brazil. Collaborating with stakeholders on program execution while ensuring ethical standards.
About the role
- Director for US Regulatory Affairs at Lundbeck leading end-to-end labelling processes for new and revised labels. Collaborating with cross-functional teams to ensure compliance with global regulatory standards.
Responsibilities
- Lead development of labelling strategy for new products and/or label revisions for existing active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch
- Supports Lundbeck Product Labeling Committee activities as LPLC reviewer/Deputy Chair, coordinating and collaborating with LPLC Chair, GSL Team and cross functional partners to ensure adherence to processes and procedures related 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 develop competitive and optimal target product labelling, CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business strategy and regulatory requirements
- Ensures effective planning and execution of all cross-functional labeling activities to maximize timebound high quality deliverables
- Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support
- Liaises with CFTs to support labeling related 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 impact to active 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 within 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 lead 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 enable process management and compliance
- Agile minded, with experience in global process improvement efforts
- Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective
- Deep experience in labelling regulations and label development management
- Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory labeling and systems problems
- Ability to influence division management at all levels to support regulatory compliance needs
- Highly proficient in communicating strategic and tactical issues to management
- Effectively able to multi-task within assigned deadlines
- Excellent written and oral communication skills
Benefits
- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
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