Regulatory Affairs Jobs

Build and maintain internal IP portfolio world-wide:
Practice area will focus on DNA-encoded libraries and small-molecule pharmaceuticals, but will include biological assays, formulations, new medical uses, etc.

Job Responsibilities

Supervises intellectual property litigation, e.g., litigation to enforce company’s intellectual property or to defend against actions brought by third parties.
Manages outside counsel.
Keeps internal management informed of status.
Conducts litigations in a cost-effective manner.
Responds to discovery requests.
Works with in-house and expert witnesses.

RESPONSIBILITIES:

· Provide strategic advice and counsel to international and affiliate management and others within company concerning international patent issues.

· Coordinate development and implementation of international patent strategies with internal patent prosecution group and therapeutic area attorneys.

Job Responsibilities

This position oversees the development of advanced delivery systems for BioPharma compounds from early development to registration and launch. Establishes processes for optimizing drug product development process setting development strategy and adherence to timelines. Ensures capture of intellectual property.

Basic qualifications:

• Minimum BS degree - Science based first degree is required.
• Requires knowledge of the relevant science conducted in Safety Assessment (non-clinical / toxicology) and its role in drug development.
• Experience of working to WW Regulatory expectations and GLPs e.g. OECD, FDA, EU etc.

Preferred qualifications: