Regulatory Project Manager / Regulatory Affairs Manager (RAM)

REGULATORY PROJECT MANAGER / REGULATORY AFFAIRS MANAGER (RAM) GAITHERSBURG, MD Onsite preferred, will consider remote. Project Description:

• The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
• The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, whilst leading simple through to more complex regulatory applications and managing procedures through to approval.
• The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

• Understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Providing regulatory input 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 of documents (e.g., response 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.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product's lifecycle from either a global and/or regional perspective.
• 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 propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.

• Relevant University Degree in Science or related discipline.
• Must have clear global regulatory project management experience and reg innovative medicine experience.
• Regulatory experience within the biopharmaceutical industry or at a health authority or other relevant experience.
• Candidates with only CMC (chemistry, manufacturing, and controls) or Reg Medical Device experience are not qualified for this role.
• General knowledge of drug development.
• Drug development experience managing INDs (Investigative new drug applications), NDAs (New Drug Applications), CTAs (Clinical Trial Applications), MAAs (Marketing Authorization Applications), or BLAs (Biologics License Applications).
• Strong project management skills.
• Leadership skills, including experience leading multi-disciplinary project teams.

• Managed regulatory deliverables at the project level.
• Thorough knowledge of the drug development process.
• Knowledge of the C Business and processes.
• Excellent written and verbal communication skills.
• Cultural awareness.
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
• Proficiency with common project management (e.g., MS Project) and document management tools.
• Ability to work independently and as part of a team.
• Influencing and stakeholder management skills.
• Ability to analyze problems and recommend actions.