US-MA, Global Program Regulatory Manager 219213BR-MZ
Global Program Regulatory Manager
Global Drug Development
REG AFFAIRS GDD
Research & Development
Global Program Regulatory Manager (GPRM) provides regulatory leadership for early projects in the Oncology Translation Medicine (TCO) portfolio. This individual functions as a core member of Early Program Teams (EPT) to define the optimal regulatory strategy for first in human (FIH) and proof of concept (POC) studies that also enables full development. The GPRM serves as a regulatory expert for TCO and EPTs to assure an understanding of regulatory processes, best practices and compliance.
Serves as regulatory representative to early clinical development and research project teams and to government regulatory agencies.
Provides strategic regulatory direction to teams on clinical trial application submission strategy, interaction and negotiation with regulatory agencies. Serves as a regulatory liaison on the project team throughout early development.
Provides advice to teams on several aspects of drug development, with major focus on early development, based on appropriate regulations and their interpretation.
Ensures that pre-clinical and clinical trial designs meet regulatory requirements.
Supports the successful completion of major programs and may function in a project leadership regulatory role.
For projects assigned as DRA Lead, lead the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports. Provides regional regulatory expertise (strategic and operational) to other DRA Leads
Ensures rapid and timely approval of clinical trial applications.
May interact and negotiate with regulatory agency personnel in order to expedite approval of pending applications and answers any questions.
Coordinates, reviews, and may prepare reports for submission. Coordinates and maintains reporting schedules for assigned compounds.
Participates in one or all of the following activities: early development plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC).
Applies extensive technical expertise and has full knowledge of other related disciplines.
Develops technical solutions to complex problems which require the regular use of ingenuity and creativity.
Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results.
May represent organization as prime technical contact on contracts and projects. May interact with senior external personnel on significant technical matters often requiring coordination between organizations.
Effective matrix management of interfaces with DRA staff, DRA operational staff, CMC regulatory and external collaborations.
Key Performance Indicators
Successful global regulatory strategy as defined by:
Timely submission of high quality IND/CTAs that maximize the probability of approval and minimize clinical holds and other delays
Identification of significant risks and options for addressing them in the regulatory strategy
Successful Early Development HA interactions that facilitate program timelines and ensure smooth transition of programs from TCO to Full Development
Successful communication of regulatory risks and alternate approaches to EPTs and management, to gain a common understanding of regulatory hurdles
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience. Prefer a strong background in molecular biology, biochemistry, or toxicology.
Fluency in English as a business language. Additional language is an asset.
3-4 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is an asset.
Oncology background highly preferred.
Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is an asset.
Involvement in an IND/CTA submissions and approval.
Regulatory operational expertise
Experience with HA negotiations
Innovation and strategy
Experience working in matrix environment or cross-functional teams.
Strong interpersonal, communication, negotiation and problem solving skills
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