For The Candidates

Manager Regulatory Affairs

Reports to: Director Regulatory Affairs & Compliance             

The Regulatory Affairs Manager is responsible for the overall development, implementation & adherence to the Annual Product Review & External Audit/Inspection Management Programs.  In association with this authority, the management position is directly tasked with completion of Annual Product Reviews, maintenance of Customer Quality Agreements, oversight of State Licensing/Registration requirements & review of applicable Label Copy.

The management position is directly tasked with review and approval of documents associated with the implementation of the programs detailed above, as well as identification and implementation of agency compliance initiatives while providing resources to investigate and mediate product complaints & support submission efforts to regulatory agencies.  Performance of duties associated with the management position requires extensive cooperation with the Registration Compliance & Reliability and Quality Engineering Management; under the direction of the Director of Regulatory Affairs. 

Reference Section II for specific responsibilities associated with performance of duties.

The below description of duties is intended as an illustration of routine responsibilities, it should not be considered all-inclusive.  Additional responsibilities may be assigned per Facility Management.

Annual Product Review

• Responsible for the overall development & implementation of the Annual Product Review Program.  Tasked with providing assurance that the overall program meets requirements as specified by applicable regulatory/authoritative bodies, as well as consistency with industry standard practice. 
• Responsible for maintenance of a policy of ?continuous improvement,? by way of consistently reviewing the Program against changing regulatory requirement, as well as for impact to the Facility?s business need. 
• Responsible identification of critical deliverables, and communication or management of these deliverables across the applicable functional areas of the Facility.

External Audit/Inspection Management

• Responsible for the overall development & implementation of the External Audit/Inspection Management Program.  Tasked with providing assurance that the overall program meets requirements as specified by applicable regulatory/authoritative bodies, as well as consistency with industry standard practice. 
• Responsible for maintenance of a policy of ?continuous improvement,? by way of consistently reviewing the Program against changing regulatory requirement, as well as for impact to the Facility?s business need. 
• Responsible for the response to regulatory agency communications as requested by the Director of Regulatory Affairs.
• Responsible for the generation of Standard Operating Procedures, Technical Position Papers & review of product labeling to ensure alignment with regulatory agency requirements.

Submission

• Assists the Director of Regulatory Affairs in the preparation and execution of regulatory submission strategy.
• Authors, monitors & provides oversight to regulatory product schedules pertaining to CMC documentation associated with clinical trial applications & marketing authorization applications.
• Responsible for maintenance of documentation library in support of Customer submission/filing amendments, supplements & annual reports.

Licensing/Registration

• Acts as the primary liaison with State & Federal regulatory bodies, as well as customers during audit or assessment of operations occurring within the Facility.
• Responsible for the proper identification of required licenses, as well as attainment of applicable licenses, in order to support manufacturing and distribution operations of the Facility.

Compliance Initiatives

• Responsible for the establishment of key performance indicators associated with the Regulatory Affairs Department, as well as monitoring & reporting of these indicators at the direction of the Director of Regulatory Affairs.
• Responsible for the investigation & mediation of product complaints.

Education or Equivalent:

• Bachelor Science degree preferred or 10+ years equivalent experience within a compliance and/or regulatory affairs role. 

Experience: 

• 10+ years progressive experience in quality, preferably regulatory compliance within a pharmaceutical manufacturing operation. 
• 3+ years leadership experience
• Demonstrated knowledge of industry related Agency requirements
• Participation in FDA, customer, and/or other external audits

Knowledge/Skills Requirements:

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work independently on multiple projects.
• Be knowledgeable.  Bring experience to the organization.  Learn new skills; collect new information.  Demonstrate a willingness to share skills and information with others.
• Demonstrate initiative.  Develop ideas, and collect them from others.  Continuously seek opportunity. Be detail oriented.  Clarify issues, investigate
• Excellent documentation skills.
• Excellent problem solving and analytical skills.
• Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
• High level of attention to detail.
• Make sound judgments. 
• Meet deadlines and work under pressure with limited supervision.
• Must be able to interact effectively with a variety of individuals and personalities within and between departments.
• Possess and demonstrate excellent verbal, written and interpersonal communications skills.
• Should be familiar with cGMP and safe work practices.
• Strong problem solving and analytical skills.
• Works well in a team environment.
• Works well under pressure and able to prioritize workloads.

Physical Requirements: 

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
• Occasional bending, grasping, carrying, stooping, kneeling, crouching
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds

Business Environment: 

• Fast-paced
• Performance driven
• Customer focused
• Collaborative and inclusive