Submission Planning Manager
The Submission Planning Manager, Regulatory Affairs Operations supports the development of submission plan created for, and as a result of, worldwide regulatory submissions. This individual collaborates cross-functionally and applies strong project management skills and knowledge of global regulatory dossier practices and requirements to drive the execution of submissions. This individual also supports the systems and processes by which regulatory documentation (internally generated or received) is created, approved, submitted, maintained for use and made readily searchable and accessible.
The Submission Planning Manager, Regulatory Affairs Operations ensures team alignment on submission content plans and is accountable for submission timelines for assigned projects. This individual is also responsible for tracking the progress of all components of a regulatory submission dossier. He/She acts as Subject Matter Expert (SME) for producing a dossier that is compliant with the required format (i.e. eCTD, NEES, paper, etc.) and that is in alignment with the submission strategy.
The individual works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.
The Submission Planning Manager, Regulatory Affairs Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Leads and drives cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory obstacles, identifying emerging issues and proactively developing solutions. This also includes responsibility for the planning and execution of all submissions throughout a product’s lifecycle (i.e. early/late development, post-marketing, etc.)
- Leads and facilitates submission planning meetings to ensure clear communication of the project plan, actions items, risks and decisions to the team
- Independently manages multiple regulatory submission projects, including the development of submission content plans
- Ensures that all regulatory content and information is appropriately tracked, archived, searchable and accessible
- Enters and tracks project and submission data in Regulatory Information Management system
- Works directly with regulatory leads to develop submission content project plans
- Works directly with publishing colleagues and external, third party vendors, to ensure an accurate and quality assembly of submission dossiers
- Leads and/or participates in department initiatives focused on the improvement of regulatory submission management processes and tools. This may include developing and contributing to new regulatory processes and providing training support as appropriate
- Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory submission-related activities. Updates internal processes to ensure compliance with health authority requirements and expectations
- Bachelor’s degree and a minimum of 5 years progressively responsible experience in a pharmaceutical, biotechnology or contract research organization (CRO) or related environment OR equivalent combination of experience and education
- Demonstrate ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status
- Demonstrate ability to define, and lead the implementation of, process/system improvements related to regulatory submissions
- Demonstrate expertise utilizing eDMS applications used for regulated document control, preferably in a pharmaceutical or biotechnology company
- Proficiency with Microsoft Office (including MS Project)
- Excellent verbal and written communication 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
- Experience managing/overseeing relationships with third party vendors
- Project Management Professional (PMP) Certification
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.