- Serves as LPLC chair, coordinating and collaborating with Global Strategic Labelling leadership and cross functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance.
- Provides regulatory expertise for the development and post-approval maintenance of global labelling, ensuring cross functional communication and execution per process.
- Partners with cross functional team to ensure development of target product labelling, as well as marketing registration labelling materials for the FDA and EMA.
- Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support.
- Coordinates cross functional support to ensure compliance of global requirements.
- Liaises with Regulatory bodies regarding label development and change management.
- Provides high-level RA advice and identify regulatory requirements for labelling development and compliance.
- Assesses supporting information to support label language against regulatory requirements.
- Maintains awareness of global regulatory legislation and assess impact to marketed and development 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).
- Accredited Bachelor's Degree
- 10+years of experience within apharmaceutical, medical device and/or biotech industry, with 7+years ofexperience in Regulatory Affairs
- 3+ years of experience developing and maintaining labelling compliance 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 regulatory strategies.
- Knowledge of development and registration timelines and requirements, 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 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
- Accredited Bachelor's Degree in life sciences
- Masters. Doctorate Degree or MBA, other professional certifications.
- CMC Experience
- Exposure to international regulatory affairs, including participation in submissions to ex-US authorities
- Ability to travel up to 20% international travel may be required.
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Director US Regulatory Global Strategic Labelling - Deerfield, United States - Lundbeck
Description
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth
Remote Opportunity - Open to candidates anywhere in the greater United States
SUMMARY:
The Director, US Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the global labelling, including critical implementation of label as driver process and efforts to harmonize US and global processes, to ensure the successful development and approval of product labelling, as well as compliant lifecycle management. Responsible party for the Lundbeck Product Labelling Committee (LPLC), serving as liaison for cross functional governance bodies, such as Safety Committee/Board and US labeling committee. Collaborates with cross functional team to support implementation and control of labelling, and directs a cross functional resources to ensure global requirements and expectations are achieved in an optimal and compliant manner.
ESSENTIAL FUNCTIONS:
REQUIRED EDUCATION, EXPERIENCE AND SKILLS:
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
TRAVEL:
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:$200,000 - $235,000andeligibilityfor a25%bonustargetbased on company and individual performance,and eligibilityto 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.Additional benefits information can be found onoursite.Applications accepted on an ongoing basis.#LI-LM1, #LI-Remote
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
Director US Regulatory Global Strategic Labelling professionals in Deerfield Beach
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Damian Lew
Project Manager in Medical Device