R & D Partners

Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.. Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations). Experience in developing CMC regulatory strategy. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team.. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.

senior manager

Job Description R&D Partners is seeking to hire a CMC Senior Manager in New Brunswick, NJ. Your main responsibilities as a CMC Senior Manager: <ul><li> Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. </li><li> Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision. </li><li> May be responsible for the global regulatory evaluation of CMC change controls with supervision. </li><li> Work with CMC cross-functional teams and Regulatory Affairs teams. </li><li> Develop and maintain knowledge of regulatory environment, regulations and procedures.. </li></ul>What we are looking for in a CMC Senior Manager: <ul><li> Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)</li><li> Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations</li><li> Experience in post-approval requirements</li><li> Experience in developing CMC regulatory strategy</li><li> Experience in project management. </li></ul>Company Description R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities. R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

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