Senior Director US Regulatory Global Strategic Labeling - Remote Opportunity

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 in the greater United States, preferably East Coast or Midwest
SUMMARY:
The Senior Director, Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the global labelling, including critical process implementation label as driver, technical and strategic support for development of label language and registration regulatory strategies to ensure the successful development and approval of assigned drug and biological products. Manages team to support implementation and control of US labelling, and directs a cross functional team to ensure global requirements and expectations are achieved in an optimal and compliant manner.
ESSENTIAL FUNCTIONS:

• Serves as global labelling leader, managing the processes and procedures related to global labelling development, maintenance, and compliance.
• Provides regulatory expertise and strategic direction for the development and post-approval maintenance of global labelling, influencing cross functional development teams and governance.
• Oversees assembly and creation of documentation to support development of target product labelling, as well as marketing registration labelling materials for the FDA, EMA, and coordinate global markets as needed.
• Responsible for the implementation and management of the Company Core Data Sheet.
• 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 scientific data for registration purposed against regulatory requirements.
• Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs.
• Trains, develops, and manages an effective regulatory affairs team on key labelling requirements, as well as key cross-functional stakeholders.
  

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor's Degree.
• 15+ years of experience within a pharmaceutical and/or biotech industry, with 10+ years' experience in Regulatory Affairs.
• 5+ Years experience developing global product labelling, with proven approval record.
• Experience with supporting both small and large molecules.
• 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.
• Deep knowledge of development program timelines and requirements, to enable cross functional process management.
• 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.
• Provider of contingencies and alternate approaches to Sr. Management and alliances.
• 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 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:

• Accredited Bachelor's Degree in life sciences.
• Masters. Doctorate Degree or MBA, other professional certifications.
• Regulatory management experience.
• CMC Experience.
• Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.
  

TRAVEL:

• Ability to travel up to 30% international travel may be required.
• Ability to support short-term assignment in US/EU, based on product registration scenario.
  

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 - $260,000 and eligibility for a 30% bonus target based on company and individual performance , and eligibility to participate in the company's long-term incentive plan. B enefits 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 on our site . ,
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 .

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About Lundbeck
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.
We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.
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About Lundbeck
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.
We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

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