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Employment Opportunities

BioDelivery Sciences International, Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. EEO IS THE LAW

 

BDSI invites any employee and/or applicant to review the Company’s Affirmative Action Plan.  This plan is available for inspection upon request by emailing mbrown@bdsi.com.  If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Michelle Brown at 919-582-9059.

 


 

Vice President, Regulatory Affairs

 

Job Title: Vice President, Regulatory Affairs

Location: Raleigh, NC

Reports To: Executive Vice President, Product Development

Education: PhD, RAC

 

Requirements

 A minimum of 5 years of industry-related experience in regulatory affairs

 

Duties

This position has responsibility for all aspects of regulatory affairs and compliance including strategy.

 

Planning

Responsible for development and execution of the company’s regulatory strategy

 

Implementation

Manage regulatory affairs and compliance staff, contracts and all regulatory affairs activities including the preparation and maintenance of clinical trial and marketing applications, and the regulatory archive.

Create and maintain company policies and procedures detailing regulatory processes.

 

Analysis

Keep abreast of changes in the regulatory environment impacting the company’s operations, interpret impact, and plan accordingly

 

Reporting

Ensure that all clinical, nonclinical, and chemistry submission documents are reviewed for regulatory suitability and compliance.

 

Communication

Lead all communications with the United States Food and Drug Administration and other regulatory authorities.

Maintain a high profile in the regulatory community.

 

Other

Duties as may be assigned.

 


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