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 Director position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data generating departments to ensure timely filing and approval of assigned oncology programs

Duties and Responsibilities:

Direct management of assigned oncology programs;

driving all submission activities (IND/CTA, trial maintenance, 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 regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;

contribute significantly to the development of regulatory strategy plans;

liaise with partnering companies to ensure regulatory alliance;

act as direct point of contact with FDA and other regulatory authorities for general issues;

mentor and coach junior regulatory staff and other team members.

Qualifications:

A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 8 years experience in Regulatory Affairs.

Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required.

Preferred qualifications:

Management experience is a plus.

Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements.

Knowledge of EU, Canada, ROW and Post-marketing a plus.

Direct experience in interacting with regulatory authorities;

experience interacting with DDMAC is a plus.

Candidates must be able to influence others and demostrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).