Senior Associate, Regulatory Affairs CMC

Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. 

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.  Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.  
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. 
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.  
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads. 
• Provide guidance on use of submission document templates. 
• Support annual reports and renewals (ad hoc baseline support)

QUALIFICATIONS

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline 
• Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
• Strong working knowledge of manufacturing unit operations or CTD structure
• Superior oral and written communication skills 
• Ability to work cooperatively with all levels and types of global personnel required 
• Experience working with electronic document management systems 
• Ability to work independently under pressure and manage multiple projects simultaneously 
• Detail/accuracy oriented 
• Collaborative and willing to learn  
• Familiarity with US and other international regulatory requirements for drug product dossiers 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.