Regulatory Manager

Regulatory Manager

 

Actavis is a leader in the development, manufacture and sales of first-class generic pharmaceuticals with operations in 32 countries, products registered in more than 60 countries, a robust development pipeline and an aggressive acquisition strategy.

 This position will be expected to take a pivotal role in guiding the Regulatory strategy of the Company, specially, designing and implementing regulatory strategy in order to meet the requirements of ANDA regulations, drafting and submitting documents, and insuring compliance on all aspects for both the products in development and already launched into the market, and regularly act as liaison with the FDA to seek guidance pertinent to the filing requirements of the company’s products Qualifications

 Lead and write the ANDA submissions and manage the daily regulatory activities.Review various documents such as Master Production Records, analytical methods and stability reports.Coordinate and assemble various materials for the submissions to the FDA such as drug product listings, annual reports.Review FDA submissions, for completeness and accuracy, prepare and submit ANDA’s, amend and supplement ANDA’s in a response to deficiency letters, federal register notices, chemistry, manufacturing and control revisions.Review labeling copy and draft advertising copy to assure compliance with government regulations.Must have the ability to read, analyze and interpret common scientific and technical journals, as well as regulatory and legal documents.Minimum of 3-5 years previous experience specifically in a hands-on role and successfully completed ANDAs (traditional and CTD) with the FDA.Solid working knowledge of regulatory submissionsExceptional interpersonal, organizational, and leadership skills as well as excellent written and verbal communication skillsAwareness of the “regulatory environment” at the FDA to anticipate and address requirements for product developmentSolid dosage experience is a mustBS/BA degree preferred3-5 years in pharmaceutical regulatory affairs

Actavis offers a competitive salary and comprehensive benefits package to all eligible employees.  For consideration, e-mail your resume in a WORD document with current compensation information to:  recruiter@actavis.com .  Subject line MUST indicate Code: Sr.DirProjectSiteMgt/LJ in order to be considered.

 

Actavis is an Equal Opportunity Employer and appreciates diversity in our workforce.