## Associate Director, Regulatory Operations
### Location
Illinois
### City
Deerfield
### Department
701 \- Regulatory
### Description
In the pharmaceutical industry, Lundbeck stands apart\. We are committed to developing and providing innovative therapies that help people suffering from psychiatric and neurological disorders\. We know the needs of those impacted by CNS disorders go far beyond the availability of medications\.
With an unwavering commitment to making a difference for patients, Lundbeck’s key focus is on such disorders as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases\. Recognizing the importance of support beyond treatment alone, the company also actively engages with professional and advocacy communities \-\- always having their needs as our first priority\. This central purpose shapes everything we do\.
**SUMMARY:**
The Associate Director, Regulatory Operations provides oversight for US Regulatory Affairs submissions and is responsible for the development and initiation of standard processes related to electronic submissions; and interacts with the R&D organization to facilitate and prioritize related activities\. The Associate Director, Regulatory Operations also ensures conformance with regulatory requirements, guidelines, internal standards and timelines\.
**ESSENTIAL FUNCTIONS:**
+ Oversees the operational and logistical aspects of regulatory submissions ensuring quality and conformance to internal processes
+ Manages the processes and works collaboratively with members of R&D organization to define specifications regarding submission\-related deliverables
+ Analyzes current, and develops future regulatory processes, standards and workflows; ensuring compliance with regulations for the generation of electronic submission\-ready documents
+ Develops and implements training programs for submission\-related software and processes related to submission applications, including NDA/IND/ eCTD, BLA, DMF and others for submission contributors and contributes to the implementation of document management and publishing systems
+ Ensures the success of global cross\-site resource sharing objectives by collaborating with HLu CPH Regulatory colleagues and contributing to global submission projects
+ Oversees the creation of US submission content templates and collaborates with internal R&D functions to customize to internal needs
+ Encourages and maintains a strong interface with Regulatory staff, facilitating and prioritizing the development of compliant submissions
+ Assists in the training, mentoring, management and development of RA Operations staff and ensures that standard processes are utilized
+ Contributes to the implementation of document management and publishing systems
**REQUIRED EDUCATION, EXPERIENCE and SKILLS:**
+ Bachelor's Degree in science related field or regulatory affairs
+ 10 years Regulatory and/or R&D Submission Support function experience
+ Hands\-on experience and extensive knowledge of IND/NDA/BLA/eCTD and other electronic requirements and guidelines
+ Ability to work with strict deadlines, changing requirements and changing priorities
+ Expert skills in MS\-Office Suite, Adobe Acrobat applications, electronic publishing/document/data management systems\. SPL
+ Ability to effectively manage resources to achieve business objectives
+ Excellent written and oral communication skills
**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**
+ 10 years Regulatory Affairs Operations experience
+ Proven ability to generate innovative solutions
+ Experience with Structured Product Labeling \(SPL\) submissions and technology
+ Knowledge of US Module 1 documents and processes
+ Self\-starter
+ Demonstrated ability to work effectively in a team environment and communicate with team members at all levels of the organization
**TRAVEL**
+ Willingness to travel up to 5% domestically\. International travel may be required\.
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