Manager, Global Regulatory Affairs

Manager, Global Regulatory Affairs-Growth Markets (GRA-GM)

Contract Term: 1 Year, potential to extend

Location: Nutley, NJ (Hybrid OR FULLY REMOTE)

US Based Only (TX, NJ, NY, PA)

The position could be either remote or hybrid.
The GRA-GM Manager will work closely with regulatory colleagues at affiliates/business partners to support the development and implementation of regulatory strategies to allow timely submissions, approvals, and optimal labels, by working closely with all relevant stakeholders within the company.

This position contributes to the planning, execution, assessment, and maintenance of product life cycle activities and strategies.

In addition, this person will also be encouraged to continuously expand his/her knowledge of Growth Markets regulatory environment and local requirements, acting as a point of contact between the affiliate/partner and the global functions within the company to create high-quality dossiers to enable an efficient and effective registration process aligned with the commercial objectives of the company.

Essential Functions
1. Maintains regulatory systems and databases up to date with ongoing projects and country-specific applications/information.
2. Works closely and supports regulatory activities with affiliates and business partners, including the initial review of proposed local Product Information/Package Insert content prior to Health Authority submission.
3. Contributes to the development and implementation of regulatory strategies for the assigned projects. Lead issue resolution of regulatory risks by identifying, escalating, and monitoring issues.
4. Manages resources and processes across multiple teams/functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
5. Contributes to the planning, execution, assessment, and maintenance of product life cycle activities and strategies.
6. Assists, as needed, in interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities and may participate in the phone- or in-person meetings.
7. Contributes to the department-wide workstream/initiatives, as assigned.

Requirements
BS/BA in Life Sciences in a relevant field with minimum 5 years of broad pharmaceutical industry experience, including 3 years of experience with new/innovative drug registration strategy/submissions, or
• MS with 4 years of broad pharmaceutical experience including 2+ years of experience with new/innovative drug registration strategies/submissions.
• An advanced degree (PharmD or Ph.D.) preferred
Previous regulatory experience in Emerging/Growth Markets (international) region, preferred
Experience in the Drug Development process and working with international/global project teams
• Working knowledge of relevant drug laws, regulations, and guidance’s/guidelines
• Desirable to have previous experience in the therapeutic area

• Ability to assume accountability for a project goal/objective
• Experience in leading team discussions to resolve and reach agreements on project issues.
• Excellent written and oral communication skills

Company requires all contractors providing services to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law.