Description:
Company Information:

To be completed by System Administrator

Position Summary:

This position is to support the Senior Director of International Regulatory Affairs as part of Millennium's Worldwide Regulatory Affairs Organization. Responsibilities for the Department include innovative international regulatory strategies for product development and approval (small molecule and biologics); facilitating preparation of international regulatory documents and various submissions, as well as any compliance matters; represent the company with international regulatory authorities, contractors and corporate partners; provide regulatory support for various departments, projects, and teams/committees. This position reports to the Senior Director, International Regulatory Affairs based in the US headquarters.

Duties and Responsibilities:

The Senior Manager of International Regulatory Affairs, positioned in the US, will facilitate the overall regulatory strategy to support product development and approval efforts for all pre- and post-marketing projects in non-US countries (e.g., primarily in the EU with intent to expand out to include Latin America, Asia/Pacific). This individual will help oversee CROs/contractor support for agreed predefined standards to meet planned project needs and ad hoc advice. Specific functions include:

Contributor in a multi-functional team environment; help implement the international regulatory strategy for all pre- and post-marketing projects.

Help in the development of the international component of the Regulatory Development Plan for programs in development.

Evaluate new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.

Provide guidance regarding evolving practices and requirements to facilitate effective product development and approval efforts in International markets.

Work closely with functional areas throughout the company. Advise functional areas regarding content requirements for international regulatory submissions; review documents from functional contributors for consistency and completeness.

Help select and manage CROs and contractors for pre-defined international regulatory functions.

In liaison with US regulatory peer(s), help develop core labeling for products in development as data become available.

Assure ongoing efforts towards fulfillment of international product approval conditions for marketed products.

Foster a proactive, collaborative and goal-driven organization.

Qualifications:

Basic Qualifications:

A minimum of 5-10 years of directly related regulatory international bio/pharmaceutical experience (particularly EU but other geographical areas a plus).

Extensive knowledge of EU regulations, policies, procedures, drug development guidelines and compliance.

Experience working with CROs and/or contractors.

Ability to help formulate global regulatory strategies based on understanding of the product and hands-on experience in regulatory procedures to achieve competitive and speedy product approvals.

Experience and judgment to plan and accomplish goals and objectives.

Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles in development.

Excellent negotiation and communication skills and the ability to work independently and function well in a team-orientated environment are essential.

Knowledge of eCTD; computer literate.


Preferred qualifications:

An advanced degree (MS/PharmD/PhD) is preferred.

Other non-US experience outside of EU is desirable.