Latest Job Posts

Director of Regulatory Affairs CMC (biopharma)

Location: PA
Industry: Pharmaceutical/Biotech
Job Code: 12024-02

Description:

This leadership role will responsible for a portfolio of projects from early development (pre Phase I) through to marketing approval. This includes responsibility for all CMC Regulatory projects for the development portfolio for biopharmaceuticals. As the department head of this expanding group, you will direct all CMC regulatory strategy and regulatory filings for global markets including responsibility for managing the direct interface with global regulatory agencies on CMC related matters (agency meetings, negotiating CMC agreements).

Responsibilities

•Extensive CMC Regulatory experience, including liaison with global regulatory agencies, able to deliver dossiers which comply with worldwide requirements and enable provision of compliant product.
• Experience working with early and late phase development projects.
• Demonstrated global leadership skills
• Proven expertise at leading and directing CMC aspects of global regulatory files and approvals.


Qualifications:

• Advanced degree preferred.
• Gobal CMC regulatory affairs experience.
• Substantial product development experience of biopharmaceutical molecules (monoclonal antibodies, peptides).

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.