Regulatory Project Manager
Regulatory Project Manager needed for a leading Pharmaceuticals organisation who are looking to employ an experienced Regulatory Project Manager who will be working within Oncology Regulatory Science and Strategy, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
What the role entails:
Some of the main duties of the Regulatory Project Manager will include:
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
- Submission delivery strategy of all dossiers and all application types per market and /or region
- Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. You will also contribute to process improvement
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Lead GRST & GRET sub-teams, i.e. Cross functional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
- Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
- Identify regulatory risks and communicate mitigations to Lead Regulatory Project Manager (LRPM) and cross functional teams.
- Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
- May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
- Provide coaching, mentoring and knowledge sharing within the RPM skill group. When assigned to a Lead RPM role an ARPD is responsible for leading the GRET with overall accountability for the project management of all GRET deliverables. They are also a key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission milestones. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members
- disciplines (CM/DM/AM)
What you need to be the successful Regulatory Project Manager:
In order to be the successful Regulatory Project Manager and have a chance to gain such an exciting opportunity you will ideally need to have the following:
- Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
- Thorough Knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Managed first wave Marketing Application and/or LCM submissions
- Managed complex regulatory deliverables across projects/products
This really is a fantastic opportunity for a Regulatory Project Manager to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.