Associate Director, CMC Regulatory

Apply by eMail:15346475.185@jobfrenzy1.com

Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for large molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA.

Duties and Responsibilities:

Develop global CMC regulatory strategy for development products.

Direct management of assigned large molecule development programs.

Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents).

Represent Regulatory Affairs at various project team and working group meetings.

Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.

Expected to develop and manage project timelines as well as have the ability to multi-task.

Monitor changes to development plans and provide regulatory guidance to teams to bridge changes
into the clinic.

Contribute to the development of equivalency protocols, validation protocols, and stability protocols.

Ensure the quality and content of all submissions to health authorities.

Liaise with partnering companies to ensure regulatory alliance.

Act as direct point of contact with FDA and other regulatory authorities for CMC related issues.

Mentor and coach junior regulatory staff and other team members.

Qualifications:

Basic Qualifications:
Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 6-8 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry. Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required.

Preferred Qualifications:
Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

Requirements:
See Above

Education: Not Specified

Experience: More than 5 years

Travel: None

Apply by eMail:15346475.185@jobfrenzy1.com

Job Created: Wed Oct 28 2009 04:27:06 AM
Last Modified: Wed Oct 28 2009 04:27:06 AM