Director Global Regulatory Affairs - Diabetes
Location: Bridgewater, NJ or Cambridge, MA
Job Category: Research & Development
The Regulatory Affairs Director is part of the Global Regulatory Affairs (GRA) team based in US and will serve as the Global Regulatory Team Lead (GRTL) for assigned programs. GRTL is responsible for developing all planning of regulatory projects that impact the company's business plan, and developing strategies to ensure effective achievement of regulatory business objectives.
Specific responsibilities include:
GRTL will be responsible for developing the global regulatory strategy for the projects in their remit. In this capacity, the GRTL has regulatory accountability globally for the program, working with the Global Regulatory team (regions, Regulatory CMC, Regulatory Operations, labeling) for developing robust regulatory strategies.
1.Represents GRA as a member of the cross functional project team and provides regulatory input for the projects globally. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL will work closely with members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis.
2.The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. This document will evolve over the course of a project's development, but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy.
3.The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meeting and major issue driven ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Senior Management is aware of any major issues with the project, including any changes to risks.
4.The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels.
5.The GRTL, working with the regions, will also interact directly with HAs as needed for the project.
6.The GRTL will work transversally to ensure a properly functional Global Regulatory Team and provide an environment under which all GRA team members and functions have a voice.
7.The GRTL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
8.Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and marketing authorizations.
9.Provide regulatory due diligence assessments of new business opportunities as required.
10.The GRTL will line manage, and coach/ mentor, junior staff supporting the program.
11.Depending on the program assignment, GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed.
1.7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs.