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Director Regulatory Operations

Kelly Services

Gaithersburg, MD
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Director Regulatory Operations

Jobid US41L7GT_BH1424460

Location: Gaithersburg, MD, 20898, USA

Description **Seeking a Director Regulatory Operations for a 12 month assignment in Gaithersburg, MD.**

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


**For immediate consideration, please call 732-246-0215 or email to**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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