Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences
Franklin Lakes, NJ 07417
About the Job
Responsibilities:
- Provides regulatory leadership to assigned platform teams providing regulatory guidance throughout the product development lifecycle and coordinating team inputs for regulatory submissions.
- Works with Associate Director and Platform Leaders to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans
- Foster deep regulatory partnership and drive execution of critical customer initiatives
- Takes lead regulatory role for new customer engagement with commercial leaders
- Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers' regulatory submissions.
- Takes a lead role in key business decisions and plan regulatory resources accordingly to ensure the development of an efficient organization and continuously seek for improvements in efficiency.
- Identifies and communicates potential risks and mitigations associated with regulatory strategies to partners.
- Support to customers for regulatory advice and registration of their products and interact as necessary with the U.S. regulatory agencies and Notified Bodies.
- Reviews and/or approves product marketing claims and communication, promotional materials, labelling, clinical protocols and clinical reports.
- Conducts training on regulatory issues for staff and for business partners (e.g., Platform, R&D, Marketing and Pharma Partners).
- Participates in internal/external trade, professional, and standards development organizations.
- Manages multiple projects with minimal supervision.
- B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
- Minimum five 5 years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields.
- Demonstrated project management, negotiation, and communication (written and oral) skills.
- Working knowledge of regulations for medical devices and drug-device combination products.
- Understanding of product development cycle, clinical phases, change management and marketing of pharmaceutical products.
- Experience with software and digitally connected devices.
- Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators.
- Ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Ability to adapt and respond quickly in a constantly evolving and often ambiguous environment.
Source : Katalyst Healthcares & Life Sciences