Job 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!

This position is a remote work opportunity

The Sr. Associate, Regulatory Affairs Operations works independently to support activities related to the review, tracking, compilation, publishing, technical validation, submission and archiving of regulatory submissions to health authorities i.e., FDA and HC. The Sr Associate will ensure compliance with regulatory requirements, guidelines, internal standards, and timelines. This role may also be assigned other operations related responsibilities as needed.

ESSENTIAL FUNCTIONS:

• Manages and prepares IND, NDA, BLA and DMF original and lifecycle regulatory submissions in eCTD format including technical review of critical components for accuracy, compliance with Health Authority requirements and internal standards.


• Coordinates the submission of all types of annual reports and ensures timely submissions.


• Works directly with submission owners to address any publishing related issues and ad-hoc requests.


• Utilizes various software tools and plugins to ensure documents and submissions meet all technical requirements for submission.


• Assists with development, documentation and maintenance of submission processes and training others as needed.


• Ensures document/submission index is complete with accurate publishing information.


• Supports compliant archiving of regulatory submission documentation in EDMS.


• Works in conjunction with team members for the creation of electronic submission ready documents.


• May be assigned other activities (e.g. State Licensing).

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• Accredited Bachelor of Arts or Bachelor of Sciences degree


• 4+ years of experience in Regulatory, Regulatory Operations or R&D Submission Support function within the pharmaceutical, biotech or medical device industry.


• 3+ years of experience working directly with eCTD publishing.


• Proficiency with MS-Office Suite and Adobe Acrobat Pro.


• Demonstrated experience with Adobe plugins, (e.g. ISI Toolbox, Smart Desk).


• Demonstrated proficiency with document management systems.


• Self-starter, able to work independently and flexibility to adapt quickly to changing requirements.


• Demonstrated ability to adjust priorities with strict deadlines to successfully complete multiple tasks


• Attention to detail and strong organizational skills.


• Strong written and oral communications skills.


• 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:

• Accredited Degree in a scientific field (such as Biology, Chemistry, Pharmacy)


• 1+ year of working experience with Global eCTD submissions (e.g. HC, EMA)


• Experience with working on US State Licensing renewal applications.

TRAVEL REQUIREMENTS:

• Willingness/Ability to travel up to 5% domestically. International travel may 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: $75,000 - $95,000 and eligibility for a 10% bonus target based on company and individual performance. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k. Additional benefits information can be found on our career site.

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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.

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