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Director Global Regulatory Affairs CMC Biologics - Remote Opportunity

 
Requisition ID:  3324
Location: 

Seattle, Washington, US

Date:  Sep 21, 2022
 

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!

 

This position is a remote work opportunity

 

Summary

  • Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.

 

Essential Functions

  • Serves as regulatory CMC representative on development and marketed product teams.
  • Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile.
  • Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
  • Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects and specifications/analytical methods
  • Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
  • Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications.
  • Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CRO's or others who work on the company's behalf.
  • Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
  • Support CMC QA functions, e.g deviations, general GMP/regulatory mixed topics.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate. Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly

 

Required Education, Experience, and Skills.

  •  Accredited Bachelor Degree
  • 8+ years experience in the Pharmaceutical Industry with direct experience with small molecule/biologic technical functions.
  • 5+ years’ experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing.
  • Capability to interact with CMC technical experts regarding process development and analytical issues.
  • Demonstrated success in global submission filing, approval, and lifecycle management
  • Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

 

Preferred Education, Experience, and Skills

  • Bachelor of Science or Arts Degree; life science related degree is preferred
  • Master or PhD of Science
  • Combination product (drug/device) experience preferred
  • Minimum of three (3) years People Management/ Leadership experience with proven track record of developing talent (preferred)

 

Travel Requirements

  • Willingness/Ability to travel up to 30-40 % domestic and international travel will be required.

 

The range displayed is specifically for those potential hires who will work or reside in the state of New York, Colorado and Connecticut, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $175,000 - $225,000 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. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and a company match 401k. Additional benefits information can be found on our career site.

 

#LI-GK1

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

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.

About Lundbeck

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. 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. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn