Director of Regulatory Affairs Opening

The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the a Global Business Unit for one of our key clients in the pharmaceutical industry. The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, ANDAs, SNDAs), and oversight of international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions

2. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of our client

3. Ensure alignment of regulatory strategy to business strategy across all functional areas

4. Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations

5. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements

6. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans

7. Act as business liaison to the Anesthesia Business Business Unit

8. Develop and manage budget as appropriate

9. Act as primary contact with the regulatory authorities including the planning and leadership of meetings

QUALIFICATIONS


1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Proven negotiation skills and significant experience in interacting with regulatory authorities
5. Risk management and problem solving skills
6. Ability to lead, mentor, and develop others for future growth and development
7. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
8. Established credibility with regulatory authorities

EDUCATION AND EXPERIENCE

Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred

If you have an interest in this position please send your resume and email expressing your interst to kcorliss@executivesg.com or give me a call at 207-510-6666.

What is the goal of my blog?

This blog will be a place that I can keep my candidates informed of new positions, share the exciting new of my clients and publish information important to those working in Regulatory Affairs.

Who is Katie Corliss?

I am the Executive Director of the Life Sciences Practice for the Executive Search Group. I am proud to work with a dedicated team of professionals the strive everyday to meet the needs of our clients and bring great opportunities to our candidates.

I specialize in recruiting Regulatory Affairs Professionals. I work closely with my clients to understand the needs of their organization. Having a true understanding of the clients’ objectives allows me to be successful in bringing them the regulatory professionals that will help them achieve their goals. I have made it my goal to reach out to dedicated group of regulatory professionals, learn what they do, why the do it, and what they are looking for in their long term career goals. I am then able to see my candidates grow professionally in positions that they enjoy and watch my clients achieve their goals and continue to grow,I am please to have strong relationships with both small up coming biotechs and large multinational pharmaceutical companies and medical device companies.

I bring to ESG a background in healthcare administration that gives me a unique view of the industry and ability to understand the long terms goals my clients have to bring new healthcare solutions to their customers.