SUMMARY: The Manager, Regulatory Strategy (US RA): supports creation and implementation of regulatory strategies ensuring successful development and approval of assigned US drug and biological products (developmental and marketed products); participates on cross-functional teams ensuring that US requirements and expectations are met in an optimal and compliant manner; helps ensure compliance with regulatory requirements and corporate standards; maintains candid and positive communications with cross functional partners and operational support.
This position provides regulatory guidance to internal business partners as requested; executes regulatory review and approval confirming submissions are consistent with product labeling, current FDA regulations, guidance documents and internal SOPs. This role may also assist with process optimization efforts and support regulatory training initiatives, as appropriate.
Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Represents US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies risk, escalates concerns, problem-solves, and offers solutions. Supports related FDA submission activities in compliance with current regulations and guidance.
Working with US regulatory management and the Global Regulatory Lead, assists with the development and execution of US regulatory strategy for assigned products.
Acts as FDA contact for assigned products. Liaises with regulatory authorities as needed.
Processes regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
Assists in monitoring the external regulatory climate to inform internal customers of potential impact on long-term objectives.
Identifies process improvement efforts supporting necessary compliance enhancements and departmental efficiencies and drives implementation of processes enhancements.
Responsible for creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product’s lifecycle.
Provides high-level RA advice and identifies US regulatory requirements for clinical studies and marketing.
Assesses scientific data for proposed registration and labeling against current FDA guidance, regulations, and precedence.
Facilitates policy and development of standard interpretation of US regulations.
Maintains awareness of US regulatory legislation and assesses its impact on business and Lundbeck product development programs.
Completes internal and external training on departmental initiatives and for compliance purposes.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
Accredited Bachelor’s Degree
5 years’ experience within the pharmaceutical or biotech industry with at least 2 years direct experience in US Regulatory Affairs
Direct experience in US drug development and regulatory submissions
Familiarity in following scientific arguments, proficient in understanding scientific data and regulations as related to drugs and/or biologics
Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team
Excellent oral and written communication skills, including ability to articulate regulatory positions
Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches, with supervision
Experience with supporting investigational and marketing application submissions and approvals
Ability to communicate strategic and tactical regulatory issues to all levels of management
Ability to work independently with a strong eye for detail and organizational skills; the ability to meet multiple deadlines and multitask within assigned projects
High proficiency in MS Word, MS Excel, Adobe Acrobat, and regulatory electronic document management systems
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Advanced Degree in Science, Chemistry, Pharmacy, Regulatory Affairs or related subject study
Familiar with Biologic Drug Development
Familiar with Chemistry, Manufacturing and Controls information
Professional certifications (RAC-drugs or RAC-US)
Willingness/Ability to travel ~5% domestically to business meetings and learning experiences.
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.
Internal Number: 1738
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!