Regulatory Operations Manager - Multiple Positions Open

Job Description
The Manager, Regulatory Review is responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical and medical/surgical device clients for promotional materials. This includes managing components of a submission package based on project type, experience working in Veeva and/or various other submission platforms, managing reference library uploads [includes collecting and validating according to SSW or clients’ specifications], facilitating communication among team members about the status of active projects, training brand teams, and data entry. This role also supports others in the dept by reviewing submissions, training and onboarding staff, identifying ways to improve process and efficiencies, and alerting others to changing submission practices. The ideal candidate for this role will be knowledgeable about projects and processes across Saatchi & Saatchi Wellness (SSW) teams regarding submission preparation and delivery. This role may have direct reports at the Associate/Senior Associate level as appropriate. 
Core Duties and Responsibilities 
Provide guidance to PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) review 
Submit completed materials to the client, both electronically and/or in hard copy, as determined by the clients’ specifications 
Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines 
Understand and document client mandated MLR submission requirements including maintaining a working knowledge of the client’s internal tools/systems for uploading and routing projects for review 
Train others on use/process and ensure these protocols are maintained and shared out to the dept or the Agency on a regular basis 
Prioritize work effectively to meet all client deadlines across your own assigned brands and for others in the dept 
Manage direct reports at the Associate and/or Senior Associate level as needed 
Comfort in onboarding new/existing staff and provide consistent guidance and feedback 
Comfort with having direct reports 
Act as a point of contact for internal Account and Project Management teams to answer submission questions 
Level of comfort in contacting Client’s promo as required 
Attend and contribute to internal/external team status meetings 
Collaborate with internal, multidisciplinary team members (Account Services, Project Management, Design, User Experience, etc.) 
Stay abreast of regulatory industry trends