Opportunity Description:
( 215) Area code Phili. Area
Manager - Regulatory Affairs
Description
MANAGER – REGULATORY AFFAIRS CMC
Our organization is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. We leveraged over 60 years of experience, as a generic pharmaceutical R&D and manufacturing company, to successfully transition into a growing, profitable, and technology driven proprietary branded pharmaceutical business.
We are seeking talented professionals to be a part of our dynamic and diverse team of over 500 employees. We are adding a Manager - Regulatory Affairs CMC to our Regulatory Affairs team.
RESPONSIBILITIES
Manages the regulatory CMC activities related to IND, NDA and ANDA submissions. Represents the Regulatory Affairs -CMC department in interdepartmental meetings pertaining to new product development, approval, and launch. Responsible for coordinating, preparing and/or reviewing the CMC portions of regulatory submissions. Corresponds directly with FDA personnel to facilitate the review and approval of regulatory applications. Ensures that the data and documents provided are complete and correct. Interacts with appropriate departments to obtain missing information and correct erroneous information that is intended for submission. Tracks the status of submissions as they progress through the regulatory review process. Coordinates, prepares and/or reviews responses to FDA CMC Deficiency Letters. Interprets FDA policies and guidance documents and provides regulatory opinion regarding filing strategy. Reviews/audits the CMC submissions prepared by the Regulatory Affairs Associate as needed. Conducts special assignments/projects per the direction of Regulatory Affairs management. Perform other duties as assigned.
REQUIREMENTS
B. S. in Chemistry coupled with a minimum of 5 years of job experience and/or formal training in Regulatory Affairs is preferred. Regulatory Affairs Certification is desirable. Knowledge of Chemistry that enables the employee to evaluate analytical records and documents that are intended for regulatory review. Knowledge of pharmaceutical production that enables the employee to evaluate production records and documents that are intended for regulatory review. Knowledge of FDA regulatory requirements that enables the employee to perform effectively in this position.
Experience with the planning and preparation of CMC sections of INDs, NDAs, and ANDAs is required. Must be able to think strategically in order to optimize the timing and quality of the submissions.
BENEFITS
We offer a competitive compensation package that includes medical, dental and life insurance, short-term and long-term disability insurance, 401K savings plan, paid time-off, tuition assistance and more!
