Associate Director Regulatory Affairs

Lundbeck•Deerfield, IL

1d•Remote

About The Position

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? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Associate Director, Regulatory Strategy provides key support to the Regulatory Affairs team and pipeline programs supporting the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products). The position participates on global cross-functional teams ensuring that US requirements and expectations are achieved in an optimal and compliant manner.

Requirements

Accredited Bachelor’s Degree
8+ years R&D experience within a pharmaceutical and/or biotech industry, with 5+ years’ experience in Regulatory Affairs (an equivalent combination of education and experience may be considered).
Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and regulations as they relate to drugs and/or biologics.
Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities.
Experience successfully supporting health authority submissions, clinical trials and critical projects while maintaining agreed timelines.
Demonstrated experience in Regulatory project management and a clear understanding of US and ex-US requirements regarding submission content and format.
Previous experience with IND filings or maintenance required and previous experience with eCTD formatted submissions. Experience with marketing applications (e.g. NDA, MAA) desirable.
Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team.
Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
Experience in identifying regulatory risk and negotiating/resolving differences.
Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects.
Excellent oral and written communication skills across all levels of the organization, including ability to articulate regulatory positions.
Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches.
Ability to work independently.
High proficiency in MS Word, MS Excel and Adobe Acrobat and regulatory electronic document management systems.

Nice To Haves

Accredited Bachelor’s Degree in Science, Chemistry, or Pharmacy.
Advanced degree preferred (e.g. MS, PhD, PharmD).
Experience in Biologic Development.
Familiarity with Chemistry, Manufacturing and Controls requirements.
Strong Preference to be based in Deerfield, IL Office

Responsibilities

Provide regulatory support and guidance to various cross-functional teams. Ensure all applicable regulatory requirements are considered and appropriately incorporated into activities and deliverables for clinical and commercial products and programs.
Provided regulatory support in authoring and editing of regulatory documents (e.g. Meeting requests, query responses) as needed.
Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings.
Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure compliance with regulatory obligations, relevant regulations, and guidance (e.g., ICH, FDA, EMA, etc.) prior to submission.
Manages the processing of 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.
Proactively identify regulatory risks and provide recommendations for risk-benefit assessments risk mitigations.
Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives.
Assists or leads improvement efforts supporting necessary compliance enhancements and departmental efficiencies.
Manages assembly and 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’s, regulations, and precedence.
Facilitates policy and development of standard interpretation of US regulations.
Maintains awareness of US regulatory legislation and assess its impact on business and Lundbeck product development programs.
Completes internal and external training on departmental initiatives and for compliance purposes.