Senior Manager, Regulatory Affairs CMC

• Regulatory professional with 5+ years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with 2-3 years in Regulatory Affairs-CMC

• Bachelor’s degree or equivalent in a related discipline. Science or pharmacist major is preferred. An advanced degree in a related discipline is preferred.

• Familiarity with global regulatory guidelines and requirements specific to the CMC development and commercialization of small molecules. Ability to interpret global regulations and guidance

• Understanding of the U.S. and EU regulations and expectations for pharmaceutical products, standards for quality, data requirements and knowledge of the regulatory review and approval process

• Experience with generating a technical registration dossier for the US and EU is preferred

• Experience with small molecule drug development, late stage drug development, and commercial stage programs is a plus. (knowledge of pharmaceutical development, including drug substance, drug product and analytical methods)

• Strong familiarity with typical regulatory submission processes and systems (e.g., submission content plans, timelines,  eCTD submissions (Module 2.3 and 3), VEEVA – RIM/EDMS, change control impact assessments)

• Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)

• Outstanding interpersonal and communication (written and verbal) skills

• Ability to influence, facilitate issue resolution, and manage conflicts is a plus.

Your responsibilities include

1. 1

   leading/coordinating execution of (CMC) regulatory filing strategy, and managing or supporting regulatory processes to achieve timely submission

2. 2

   preparing high quality CMC regulatory documents or packages in accordance with company standards and procedures, ensuring thoroughness, accuracy, and timeliness

3. 3

   building strong collaboration with internal stakeholders, including Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain; providing functional expertise to matrix/cross-functional teams

4. 4

   maintaining current knowledge of regulatory intelligence and processes that may impact regulatory-CMC planning; proactively monitoring changes in the regulatory environment to better inform stage-specific CMC requirements for clinical development programs

5. 5

   providing regulatory support for relevant Quality and Regulatory processes and systems such as change controls and VEEVA - RIM

6. 6

   communicating status and potential risks to defined regulatory strategies, timelines, or approvability

7. 7

   assisting preparation of teams or materials to support regulatory authority interactions or internal communications at the team or governance level

8. 8

   supporting or leading non-program-specific projects as assigned (e.g., department initiatives, training, due diligence, etc.).