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Director, Regulatory Strategy

Date: Mar 8, 2019

Location: Deerfield, Illinois, US

Company: Lundbeck

At Lundbeck, we believe life is too precious to be interrupted by brain disorders. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. We pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer's disease and Parkinson's disease. 

 

For Lundbeck, making a meaningful difference for patients is more than an aspiration; it is a commitment that shapes everything we do. Patient advocacy is at the core of who we are and motivates every individual at Lundbeck. Our engagement with the communities we serve grants us better understanding of the needs of patients and their families; and that drives us to develop innovative therapies and impactful programs for patients and caregivers.

 

SUMMARY: 

The Director, Regulatory Strategy oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products.  Directs a cross functional team to ensure that global and/or regional requirements and expectations are achieved in an optimal and compliant manner.

 

ESSENTIAL FUNCTIONS:

  • Serves as US and/or global product registration leader, influencing cross functional development teams and boards.
  • Oversees assembly and creation of documentation to support investigational and marketing registration packages throughout the world.
  • Liaises with global regulatory authorities as needed for all aspects pertaining to drug development and approval.
  • Provides high-level RA advice and identify regulatory requirements for clinical studies and marketing approval in domestic and international markets.
  • Assesses scientific data for registration purposed against regulatory requirements.
  • Facilitates policy and development of standard interpretation of global regulation.
  • Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs.
  • Trains, develops, and manages an effective RA team on a dotted-line basis (CMC, RA Operations, Labeling and Promotion, International, CPT Regulatory Satellite Team).

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Advanced degree in a relevant scientific discipline.

  • 8+ years in the pharmaceutical and/or biotech industry.
  • 6+ years’ experience in regulatory.
  • Ability to lead and work in cross-functional, matrixed and multinational teams.           
  • Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
  • 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 convince 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 Master’s degree in life sciences, MBA, Doctorate Degree or other relevant professional certifications.

  • 10+ years R&D experience within the pharmaceutical and/or biotech industry.

  • Divisional RA leadership experience.
  • Demonstrated record of investigational and marketing application approvals.
  • Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.

 

TRAVEL

  • Willingness/Ability to travel up to 20% domestically. International travel will occasionally be required.

 

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.