Remote/Commuter Opportunity - Open to candidates within the United States

SUMMARY:

The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end- to- end (e2e) labelling process for development of new and/or revised labels, as well as strategic labelling development for pipeline assets. Will champion the implementation of label as driver process from early development through regulatory approval. The individual will be responsible for Global strategic Labelling (GSL) efforts to harmonize US and global processes for ensuring streamlined e2e labelling development and approval, as well as compliant lifecycle management. The individual will serve as a reviewer for the Lundbeck Product Labelling Committee (LPLC) and related labelling compliance activities and may serve as liaison for cross functional governance bodies, such as Safety Committee/Board and LPLC. Collaborates with cross functional team to support development, revision, maintenance and implementation of labelling, while ensuring global and regional requirements and expectations are achieved in an optimal and compliant manner.

ESSENTIAL FUNCTIONS:

• Lead development of Global 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, coordinating and collaborating with LPLC Chair/Deputy 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 (TPL), 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, Safety, Clinical and International regulatory).

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor’s Degree in life sciences.
• 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in Regulatory Affairs.
• 5+ 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.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Masters in science related field. Doctorate Degree or MBA, other professional certifications.
• Global Regulatory Affairs Experience.
• Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.
• Strong Preference to be based in Deerfield, IL Office

TRAVEL:

• Ability to travel up to 20% domestic/ international travel may be required.
• Ability to support short-term assignment in US/EU, based on product registration scenario.
• If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $220,000 - $250,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k.