Sign in

Regulatory Affairs Director : Remote

Company:
Artech Information Systems
Location:
Gaithersburg, Maryland, United States
Posted:
November 09, 2018

Description:

Job Description:

Job Title: Regulatory Affairs Director

Location: Remote

Position Summary:

Main Duties and Responsibilities

We are currently seeking a Regulatory Affairs Director (RAD) to join our Global Regulatory Affairs team. As the Regulatory Affairs Director you will be accountable for the development and implementation of the regulatory strategy for a product or group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Regulatory Affairs Director possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or Global Product Teams (GPT), Investigational Product Teams (IPT) and relevant stakeholders. The Regulatory Affairs Director has the ability to take on the Global Regulatory Lead (GRL) role for a product/group of products.

As the Regulatory Affairs Director, additional duties include accountability for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business and patients, leading and developing a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements, leading the planning and construction of the global dossier and core prescribing information and leading the development and implementation of innovative strategies to maximize the likelihood of regulatory success.

Essential Requirements

• Bachelor's degree in a science related field and/or other appropriate knowledge/experience.

• Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions.

• 5 + years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas.

• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.

• Proven leadership and program management experience.

• Ability to think strategically and critically evaluate risks to regulatory activities.

• Ability to work strategically within a complex, business critical and high profile development program.

• Successful contribution to a major regulatory approval at a global or regional level.

• A scientific and clinical understanding of the regulatory sciences.

• Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.