Regulatory Affairs Manager

Location: Remote
Department: Life Science

Job Description

Voted one of the Top Workplaces in the Lehigh Valley, our exceptional team is both the reason for and the product of Adept Group’s success. Our associates lead projects for iconic brand owners, build their skillsets through working on a range of innovative projects and collaborate with our technically gifted team to produce unparalleled results. 

Adept Group is a great place to showcase your expertise and build upon your skillset while having fun with some amazing people from a variety of backgrounds. We’re driven, inspirational and most importantly, human. We infuse who we are into everything we do. We offer a flexible, collaborative environment that embraces diversity, celebrates achievement, thrives on challenge and actively seeks out opportunities to invest in our clients, our communities and one another. 

Description: 

Adept Group has the largest global team of packaging industry experts, providing services and tools to effectively execute projects, fix issues, improve internal capabilities, and deliver our clients’ objectives. 

Adept is hiring a CMC Regulatory Affairs Manager to support Adept’s fast-growing Life Science Practice. The ideal candidate selected for this role should have experience in the Life Science industry and be able to provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure our client’s products are developed/maintained in compliance with global regulatory requirements and guidance. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. 

Key Responsibilities: 
 

  • Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products. 
  •  Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries. 
  • Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).  
  •  Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.  
  • Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.  
  • Provide regulatory assessment in change management.   
  • Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.. 
  • Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings. 
  • Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.   
  •  Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, Concur (expenses), and Powerpoint. 
  • Performs other duties as assigned. 

Qualifications 

Knowledge: 

  • Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues. 
  • Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products. 
  • Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada 
  • Comprehensive understanding of the global regulatory environment. 
     

Skills: 

  • Proactive strategic thinker 
  • Operationally minded (know how to prepare a high-quality technical document or submission using internal systems) 
  • Strong analytical, problem solving, organizational and negotiation skills. 
  • Strong collaborative inter-personal, communication, presentation and meeting leading skills. 
  • Strong ability to work in matrixed environment and across cultural lines. 
  • Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)  
  • Ability to function in a fast-paced environment 

 

Education:  

  • Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biolog 
  • RAC certification a plus 

Experience: 

  • 5 to 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead 
  • Experience with directly authoring Module 2 and Module 3 documents as well as IMPDs  
  • Background with Investigational and Approved Filings 
  • Background working with small molecule and biologics


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