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Regulatory Affairs Director – Phoenix

On Time Talent Solutions

This is a Full-time position in Phoenix, AZ posted June 11, 2021.

Title: Regulatory Affairs Director
– Phoenix

Date Posted: Saturday, May 22, 2021

Job Type: Permanent

City: Phoenix

State: Arizona

Regulatory Affairs Director

Phoenix, Arizona

Known widely for its beautiful wildlife, deserts and outdoor activities, Phoenix is home to more than 1.5 million people.

In 2018, Phoenix gained over 85,000 new jobs, with a projected 28,000 new jobs over the next two years, making Phoenix a great place for individuals or families relocating.

Whether you are looking to relocate or are a current resident, job opportunities in Phoenix are abundant.

On Time Talent solutions is seeking a Regulatory Affairs Director who will be responsible for leading preparation of regulatory submissions to support global clinical development, product registration, and post-approval life cycle management.

This position will provide overall leadership and regulatory direction on projects by working with internal program teams to develop regulatory strategy and development plans and will interface with external consultants and regulatory agencies in developing regulatory submissions.

Regulatory Affairs Director Responsibilities:

Work with multidisciplinary project groups in meeting established objectives; prioritize projects to meet internal and external deadlines; and provide regulatory guidance

Assist legal counsel and corporate clients who are primarily pharmaceutical, biotech, medical device and diagnostics companies, with complex regulatory and compliance issues

Provide leadership to resolve critical regulatory issues, bring the appropriate experts together as needed

Lead cross-functional efforts to deliver high quality submissions, e.g., INDs, CTA, orphan applications
– Ensuring that Manager is aware of any major issues with the project, including any changes to plan or risks

Keep abreast of regulatory guidance and technical/scientific developments relevant to projects

Build a Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing

Regulatory Affairs Director Qualifications:

Bachelor’s degree in life sciences, chemistry, or a related discipline, advanced degree preferred

10+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry

Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes and issues in drug development

Flexibility and responsiveness in managing multiple projects in sometimes high-pressure situations simultaneously

Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box

Regulatory affairs certification (RAC) a plus

Knowledge of both GCP and GMP regulations
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