Job Title: Senior Manager, Regulatory Submission Project Management
Job Location: Boston, MA (Remote Position)
Position Type: Direct Hire / Permanent
NOTE: Pharmaceutical Experience Mandatory. This position can be based at any of our client US office, or virtual/remote, with up to 20% travel
The Senior Manager, Regulatory Submission Project Management will be responsible for project management and planning of major, routine and non-routine submissions including oversight on content planning, documentation deliverables and submission timelines to ensure overall completeness of scheduled submissions. The Senior Manager, will be the point of contact for Submissions Leads to support submission planning, preparation of timeline overview (including author, review and approve document timelines) and coordination of Submission Sub-Team Meetings, if required. It is expected that this role will create and maintain Regulatory Project Management Tools to be used by the GRA organization i.e. Project Management Planning Templates.
- Manages submission activities related to pre-IND or Scientific Advice Submissions, INDs, BLAs, sBLAs, MAAs, amendments and variation submissions;
- Creates and manages submission plans (content plans), timelines and responsibility matrices through cross functional discussions and tracks submission deliverables to maintain the target submission date;
- Coordinates submission documents through review cycles and provides guidance to cross-functional groups uploading submission documents to the regulatory submission document management system;
- Involved in the coordination of Submission Sub-Team meetings for major submissions aligned with the GRL and submission leads;
- Identifies potential issues that could impact the target submission date and leads discussions to reach consensus around a solution;
- Manages overall completeness of scheduled submissions and cooridnates with the Publishing Lead on submission timeliness and documentation status;
- Oversight on routine regulatory submissions such as those of annual reports, PSURs, DSURs and Orphan Drug annual reports etc. (LCM activities);
- Manages Health Authority requests aligned with local and regional leads, ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop;
- Oversight on commitments;
- Manges annual forecast for Agency Meetings across programs and ensures regular communication of upcoming meetings to the leadship team;
- Responsible for forecast tracking in conjunction with the GRL;
- Involved in regulatory submission process improvement activities and establishing repeatable processes utilizing key technologies, tools and processes;
- Supports Regulatory Submission Project Management team in setting standards to ensure alignment across programs;
- Supports the development of Submission Project Management Tools to be used by the wider GRA organization.
- A minimum of 5 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Submission Project Management (project management) experience;
- Strong verbal and written communication and presentation skills;
- Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams;
- Self-motivated and results-oriented with high energy drive to mentor junior members of the group;
- Strong Knowledge of applicable Regulatory Agency regulations, guidelines and/or specifications (e.g. FDA, EMA, ICH etc.);
- Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.);
- In-depth knowledge of Starting Point templates or similar;
- Demonstrated project management, organizational and planning skills;
- Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines;
- Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities;
- Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines;
- Solid understanding of submission deliverable dependencies and ability to reflect this in project plans in order to create and maintain detailed submission schedules (as MS-Project tasks);
- In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met in a timely manner and to the highest quality.
- A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted. Advanced degree in a scientific discipline preferred;
A minimum of 5 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Submission Project Management (project management) experience.
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Hallmark Global Technologies, Inc.