Global Regulatory Lead

Where

Collegeville, PA

What you'll be doing

The proposed person will be responsible for reports to vice president. Close working relationships with research units serve as the global regulatory leader for multiple orphan assets under development as well as potentially other bio-therapeutics research assets. Work with project teams to develop and implement regulatory strategies in support of operating plans for programs including alignment of clinical and commercial targets, preparation of on-time, high-quality, regulatory submissions, understanding the regulatory requirements for key documents including regulatory submissions and registration related documents. Assess and advise teams to mitigate regulatory risks in development projects. Act as the single point of regulatory accountability for the assigned areas of focus for all incoming/outgoing regulatory interactions. Work with teams to develop toxicology, cmc and clinical strategies. Manage regulatory communications among the clinical, clinical operations, regulatory operations and global cmc groups. Collaborate with global regulatory agencies. Oversee preparation, review and editing of sections of regulatory trial documents. Provide answers to regulatory questions for program management, non-clinical and clinical team members, and develop close working relationships with these team members. Integrate knowledge, expertise and negotiation skills to resolve problems, modify procedures, and develop and interpret policy to meet evolving regulatory demands. Maintain working knowledge of relevant global guidance documents and regulations.

What your background should be

Not Specified

Required Schooling / Training

Not Specified

Who is the client company

It is an American multinational pharmaceutical corporation.

If you are interested in this position, send your resume to apply@kochdavis.com