Leads, coaches, and mentors direct reports to accomplish organizational and department priorities.
Leads the West-Ward Pharmaceuticals regulatory and labeling groups in filing new multi-source products that comply with regulatory requirements in order to obtain FDA approval of West-Ward Pharmaceuticals products. Ensures that all regulatory requirements for life-cycle products are completed on time and in accordance with FDA guidances, policies and procedures. Provides regulatory direction and strategic oversight for all submissions for both commercial and developmental projects to all functions.
Mentors, leads, coaches and develops employees; manages and addresses performance issues; and makes hiring, firing and compensation decisions to ensure individual and organizational performance currently and in the future.
Communicates site and department goals and expectations to staff.
Sets goals and expectations for staff with their input.
Ensures conditions (time, equipment, etc) necessary for staff performance are met and barriers to performance are removed.
Measures direct reports' core job/MAG performance and contribution to team performance.
Communicates site and department performance to staff.
Provides direct reports with feedback on core job/MAG performance.
Collaborates with direct reports to identify and enable their skill and knowledge development.
Rewards and recognizes staff and team performance to build engagement.
Ensures direct report positions are filled timely with the best qualified candidate(s).
Provides strategic support and decisions for all regulatory issues regarding new ANDA/NDA filings as well as life-cycle ANDAs that are approved and marketed in the US. Influences with respect to strategies and critical project issues to positively impact project goals, objectives and ultimately FDA approval.
Leads the Drug Regulatory Affairs and Labeling Teams to ensure 16 to 20 new product ANDA/NDAs are filed accurately and timely through review and approval in order to support the RLI business model.