The Manager, Regulatory Affairs Operations is responsible for supporting the development of documents created for, and as a result of, worldwide regulatory submissions. The incumbent utilizes and supports systems and processes by which regulatory documentation (internally generated or received) is created, approved, submitted and maintained for use and made readily searchable and accessible.
He/she is responsible for ensuring that documents are formatted in accordance with appropriate style guides and resolving technical issues with formatting. The manager will be responsible for managing and tracking eDMS workflows in coordination with Medical Writing and Project Management teams.
The incumbent will provide operational support in all aspects of eCTD and non-eCTD publishing.
The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.
The Manager, Regulatory Affairs Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Collaborates with cross functional teams and end users to ensure that content generated for regulatory purposes is appropriately formatted for submissions and delivered in accordance with required timelines.
Ensures that all regulatory content and information is appropriately tracked, archived, searchable and accessible for the appropriate end users.
Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities. Updates internal processes to ensure compliance with health authority requirements and expectations.
Provides end-user support for eDMS-based applications including conducting requisite training for eDMS users. Performs other tasks and assignments as needed and specified by management.
Education Minimum Requirement:
Bachelor's degree in a relevant discipline and a minimum of 6 years progressively responsible experience in a pharmaceutical, biotechnology or contract research organization (CRO) or related environment OR equivalent experience and/or education.
Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions.
Demonstrated expertise utilizing the eDMS applications used for regulated document control, preferably in a pharmaceutical or biotechnology company.
Expert Proficiency with Microsoft Word.
Proficiency with Microsoft Office (including MS Project).
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Experience supporting or administering eDMS-based applications used for regulated document control, preferably in a pharmaceutical or biotechnology company. (Veeva RIM).
Experience with eCTDXPress.
Project Management Professional (PMP) Certification.