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Associate Director Regulatory, Advertising and Promotion Compliance - Remote Opportunity

 
Requisition ID:  1421
Location: 

Deerfield, Illinois, US

Date:  Oct 27, 2020
 

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

 

This is a remote position:  Ideally situated in the Chicagoland area but open to remote candidates anywhere in greater United States

 

SUMMARY:
Under the supervision of departmental management, the Associate Director, Advertising and Promotion, Strategy and Compliance (US RA): provides regulatory advertising and promotional direction for the successful launch and lifecycle management (LCM) of Lundbeck US drug products; helps ensure compliance with regulatory requirements and corporate standards; and maintains positive communications with internal commercial partners and FDA contacts. More specifically, this position provides regulatory label strategic direction and promotional guidance to internal business partners in order to facilitate the commercial brand plan, including executing the regulatory review, approval, and submission of advertising and promotional materials to ensure consistency with product labeling, current FDA regulations, guidance documents and internal SOPs.  This role is responsible to lead and/or support departmental regulatory training initiatives both internal and external, and provide research and communication concerning advertising and promotion regulations.

 

ESSENTIAL FUNCTIONS:

  • Provides regulatory review of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations. Manages, reviews and represents regulatory perspective at PARC meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, offers solutions. Manages/supports related FDA submission activities in compliance with current FDA regulations.
  • In close cooperation with regulatory agents, coordinates regulatory promotional submissions; prepares submissions in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
  • Provides Regulatory strategic guidance on new concepts, DTC advisory processes, Consistent with FDA Label tactics, in order to identify and mitigate risk.
  • Provides Regulatory leadership on brand and life cycle management teams, process optimization efforts, development and collection of metrics, and further enhancement of cross functional interactions.
  • Provides internal and external training on departmental initiatives and for compliance purposes. 
  • Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives; Represents RA at cross-functional team meetings to represent agreed-upon RA positions.
  • Develops and facilitates improvement efforts for internal promotional material review processes, through cross functional collaboration and leadership through influence, in order to support necessary compliance enhancements and departmental efficiencies.
     

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited BS Degree 
  • 8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, medical device or biotech industry with at least 4 of those years within either advertising/promotion or Regulatory experience specific to neurology, migraine, or biologics
  • Experience and understanding of FDA Promotional Regulations, specifically of Direct to Consumer (DTC) regulations and Consistent with FDA Label guidance
  • Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
  • Proficiency in identifying regulatory risk and negotiating/resolving differences 
  • Demonstrated leadership capabilities, both with direct reports, as well as leading by influence
  • Attention to detail and strong organizational skills with the ability to meet multiple deadlines 
  • Demonstrated ability to work in a multi-disciplinary team
  • Excellent oral and written communication skills, including ability to articulate regulatory positions
  • High proficiency in MS Word, MS Excel and Adobe Acrobat       
  • Proficient in Veeva or comparable document management system
  • High Proficiency in time management and demonstrated ability to work independently        
     

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited BS Degree in Science, Chemistry, Pharmacy or related subject study/experience
  • Knowledge in the Regulatory support of both biologics and small molecules
  • Terminal Degree in a Science Field (Ph.D., PharmD)
  • Proficiency in FDA Promotional Regulations, specifically of Direct to Consumer (DTC) regulations and Consistent with FDA Label guidance
     

TRAVEL

  • Willingness/Ability to travel ~10%+ domestically to business meetings and learning experiences

 

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.

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.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.