Depomed, Inc Director, Regulatory Affairs in Lake Forest, Illinois
City Lake Forest
State Illinois [IL]
Title Director, Regulatory Affairs
Job ID 1172
Department Regulatory Affairs
Responsible for representing the Regulatory compliance voice on such matters and acts as an internal expert to advise on the FDA requirements while working closely with all stakeholders to reach consensus on approved messages and materials. This role will facilitate the generation of new, and revision of, product labeling with key local disciplines as well as external alliance partners and serve as the expert for the regulatory history for labeling and promotional communications with FDA.
ESSENTIAL JOB FUNCTIONS
• In collaboration with the VP, Regulatory Affairs, establishes regulatory strategy to support both development and commercial products.
• Maintains an in-depth knowledge of regulatory requirements and guidance and assesses impact to the organization for advertising and promotions.
• Provides education and training regarding requirements and works in collaboration with others to ensure compliance.
• Functions as the “Regulatory Voice” for project teams, with a particular focus on Clinical Affairs. Provides clear Regulatory guidance and compliant pathways to regulatory approval
• Functions as an FDA liaison on assigned projects.
• Maintains a strong knowledge of electronic submission requirements and works in collaboration with regulatory operations to ensure team members follow templates and strategy for submission.
• Med/Reg/Clin Affairs review and management of contracts – will streamline, manage and work with Legal to finalize contract approvals for all vendors, CRAs, consultants, etc.
• Audit and Regulatory Compliance for Med Affairs/Regulatory and Clinical Affairs functions; investigator related studies, clinical trials, investigator meetings, other fee for service consultant arrangements
• Systems/SOP development and training for drug safety reporting, et. al.
EDUCATION AND EXPERIENCE
• 8 - 12+ years’ experience in regulatory affairs with first-hand involvement in maintaining and managing INDs and NDAs.
• BA/BS degree or equivalent experience in related field required. Advanced degree preferred.
• Advanced skills in using Microsoft Office Suite and Adobe programs.
• Knowledge of FDA regulations and guidance as pertaining to post-approval clinical, nonclinical and submissions.
• Lifecycle management and post-approval sNDA experience are highly desirable.
• Experience with both development and commercial phases of the product lifecycle preferred.
• Excellent verbal and written communication skills
• Detail oriented, Decisive, and Adaptive to an evolving environment
• Previous experience with managing others
Assertio Therapeutic is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, orphan and specialty therapies.
Assertio has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company’s strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.
Assertio is an AA/EEO/Veterans/Disabled employer.