Summary of Position
Our client, clinical-stage biopharmaceutical company, is looking for a Senior Regulatory Operations Manager.
The Sr. Regulatory Operations Manager/Regulatory Operations Manager position is responsible for assisting the Director, Regulatory Operations in enforcing regulatory submission standards and current electronic submission guidelines/requirements. The incumbent in this role will be responsible to managing day-to-day submission-related tasks and may be responsible for mentoring other Regulatory Operations team members.Responsibilities and Job Duties
- Responsible for the preparation, dispatch, tracking and archiving of electronic submissions for developing and marketing applications.
- Represents the Regulatory Operations function in project team meetings to facilitate and assist with meeting submission timelines. When timelines are jeopardized, makes recommendations for modifications and or solutions.
- Develops and provides training on Regulatory Operations software tools and publishing concepts to junior Regulatory Operations personnel and other internal stakeholders
- Develops, revises and maintains best practices for Regulatory Operations department to ensure compliance with changing FDA/ICH regulations. Educates internal team and stakeholders on importance and relevance to ensure compliance.
- Effectively manages and interacts with internal stakeholders, vendors and corporate partners as they pertain to the development, management and validation of Regulatory Operations projects.
- Interacts with Regulatory Agencies as needed to gain clarity/guidance on Regulatory Operations topics. Communicates information with appropriate team members and/or stakeholders.
- Provides input/recommendation to project teams and/or Senior Management on electronic submissions strategies to support BLA/NDA and IND applications.
- Leads software implementation and validation projects for Regulatory Operations. Ensures that the right stakeholders and internal team members are involved at the appropriate times.
- Guides and mentors junior Regulatory Operations personnel on submission preparation and compilation to ensure consistency with submission standards and quality of content , as well as how to work effectively with document stakeholders and manage multiple priorities.
- Provides training and education to junior Regulatory Operations staff and key stakeholders of new electronic submissions/eCTD guidelines and initiatives
Education, Credentials & Experience
Bachelor's degree in the Life Sciences or a related field of study
- Minimum 8 years of Regulatory Operations experience using appropriate software tools in the biotechnology and/or pharmaceutical industry
- IND/BLA/NDA/CTA/MAA filing experience
- Experience with Regulatory Operations software/validation of systems
- Experience with Adobe Acrobat and Acrobat plug-ins such as ISI Toolbox
- Experience with eCTD building/compilation software (EXTEDO eCTDmanager preferred)
- Knowledge or experience with Electronic Document Management Systems (Veeva Vault preferred)
- Advanced experience with and understanding of US and global electronic submission requirements and guidance
Knowledge, Skills and Abilities
- Advanced proficiency in MS Office applications
- Ability to work in a scientific and technical-oriented environment
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
- Must possess ability to handle multiple priorities in a fast-paced environment
- Must possess excellent written and verbal communications skills
- Ability to independently problem solve and offer solutions to functional leaders and collaborators.
- Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
- Agility and scalability to take on increasing responsibility
- Consistent demonstration and embodiment of company Living Values
- Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical submission-related issues)
- A Bachelor's degree in a scientific or technical field of study
- Expert working knowledge of MS Word, including the ability to create Word styles, templates, ribbons/toolbars, and macros
- Knowledge of HTML/XML helpful