Position: Technical Project Manager
Location: Virtual, New Jersey 99999
Term: 11 Months
Experience - 7-12 Years
Responsibilities
- The Regulatory Affairs (RA) Senior Manager is responsible for maintaining or obtaining Health Authority (HA) approval for our client’s pharmaceutical portfolio.
- They will guide regulatory strategy in line with regional, national and international requirements and establish dossier timelines from authoring through to submission and approval at the HA.
- They will be responsible for end-to-end management of regulatory submissions including Planning, module 1, 2 & 3 authoring/review/publishing & dispatch.
- In parallel, the person assumes responsibility to assure dossier status through timely and accurate maintenance of dossier information in regulatory planning and document management systems.
- Works with colleagues from multiple regions in order to deliver a dossier that meets the technical requirement (such as but not limited to eCTD, NeES and Paper) and regional/local regulatory requirements for which the submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and the United States)
- Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines.
- Through active management of status and expected deliverables, identifies risks and formulates a strategy to mitigate those risks to quality and timeliness of submissions
- Delivers electronic and paper regulatory submissions through coordination and execution to requirements and standards of each submission and national markets.
- Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier formats and translation requirements as required.
- Assists with the interpretation of regulatory technical guidelines in order to produce business requirements and ensure that those requirements are implemented where appropriate at a local level.
- Adheres to the required use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Manages and leads a team of Reg Affairs professionals to deliver quality, first-time right, regulatory content.
- Project manages a team to ensure deliverables and service levels are met and within the agreed timelines.
- Works with the client to develop a clear and detailed plan for reporting metrics.
- Acts as the liaison/single point of contact to the client for all process-related items and participates in client governance meetings on a regular basis.
Qualifications
- Bachelor's degree required in science, engineering or related field (advanced degree preferred).
- Experience in global regulatory affairs and regulatory operations. Proven success in compiling and filing regulatory submissions and Marketing Authorizations end to end.
- Proven and relevant regulatory affairs experience in a pharmaceutical, vaccine, or biological products; or related fields.
- Proven experience in managing a regulatory team successfully, including duties such as providing regulatory strategy and guidance, reporting, tracking SLAs, training and managing client/pharma company expectations.
- Demonstrated superior oral and written communication skills in multicultural settings and the ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal and negotiating skills.
- Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
- Skilled at fostering customer relationships and driving collaboration.