Regulatory Affairs Specialist with Submissions Experience

Repligen Corporation is a profitable biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system.   We currently market two commercial products, Protein A and SecreFlo®, which partially fund the advancement of our developing clinical pipeline while supporting our financial stability.





 

 

We have an immediate interest in hiring a Regulatory Affairs Specialist who will be responsible for the development and implementation Electronic Common Technical Document (eCTD) submission capabilities (with the support of outside vendors) as well as managing day-to-day Regulatory Operation activities to support and achieve the Company’s goals.

 

 

RESPONSIBILITIES Spearhead the company’s first eCTD submission Lead the tactical short range and long range planning for systems needed for the CTD Define and implement processes governing regulatory CTD submissions as well as, CTD documenting standards, work instructions, and quality control of submissions. Develop a working timeline to submission – this includes collaborating with other departments as well as third party vendors. Ensure compliance with regulatory agency rules and guidelines pertaining to CTD submissions Together with a third party vendor prepare and submit eCTD

 

QUALIFICATIONS Bachelor’s Degree Life Sciences, Business Administration, Information Technology or related field 3 years of relevant work experience in Regulatory Operations Knowledge with ICH eCTD submission practices Excellent written and oral communication skills Strong knowledge of pharmaceutical regulations pertaining to documentation and regulatory submission