Sr. Manager, Regulatory Affairs

Sr. Manager, Regulatory Affairs

Capstone Development Services Company, LLC in Rosemont, IL has openings for Sr. Manager, Regulatory Affairs to prepare and implement U.S. and global regulatory strategy. Responsibilities include: develop regulatory strategies to facilitate US and Global programs and initiatives; maintain Global regulatory aspects of all Capstone global products; establish guidelines and regulatory requirements for combination products; maintain log of U.S. FDA Controlled Correspondences and FDA Information Requests to New Drug Applications (“A/NDAs”); evaluate regulations and design science-based registration strategies; monitor product-related activities for regulatory compliance; review documentation required in regulatory applications;  collaborate with national and international regulatory agencies; oversee lifecycle management of marketed products following regulatory approval; and oversee development of Standard Operating Procedures as they relate to Current Good Manufacturing Practice (“cGMP”) compliance. Intermittent telecommuting permitted. Position requires: Bachelor’s Degree in Biology, Biochemistry, Healthcare Management, or related field and five (5) years of progressive experience in regulatory affairs within the pharmaceutical or biotech industry. Experience must include pharmaceutical regulatory submissions and product approvals; post-approval life cycle management of marketed products; collaboration with national and international regulatory agencies including the FDA and European Medicines Agency (“EMA”), and development of procedures that adhere to cGMP regulations related to pharmaceutical products. Resumes to hr@capstonedevservices.com.