Regulatory Project Manager

Precigen - Germantown, MD

Germantown, MD

Professional, Scientific, and Technical Services

About the position

Precigen is seeking a highly motivated and skilled Regulatory Project Manager to work with our Regulatory Affairs team in Germantown, Maryland. The Regulatory Project Manager will be responsible for supporting complex filing activities, ensuring compliance with technical and regulatory standards. This role involves strategic thinking, efficient resource management, and clear communication with stakeholders and the project team. The Regulatory Project Manager identifies and mitigates risks, maintains high-quality deliverables, and implements process improvements. Resource management is crucial, along with fostering a collaborative team environment. Ultimately, this role ensures RA filings are submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and regulatory compliance.

Responsibilities

• Develop and manage submission content plans, including timelines and resources, ensuring projects are completed on time and within scope.
• Monitor and track deliverable progress, identify potential risks, and develop and implement mitigation strategies.
• Conduct regular project meetings and provide updates on status, issues, and changes to senior leadership and stakeholders.
• Ensure that regulatory reporting and documentation requirements are met, including the development of reports, presentations, and updates.
• Maintenance and tracking of regulatory submission documentation, including regulatory authority correspondence, in an appropriate electronic document management system(EDMS) or hardcopy archive location to ensure regulatory compliance and in accordance with company document standards.
• Coordinate submission planning and timelines with internal publisher and/or external vendor to publish submissions.
• Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provision of needed data and documents; keeping our Affiliates informed about new products/projects/process changes etc.
• Contribute as needed to answer Health Authority questions on the submissions and track commitments to Health Authorities.

Requirements

• Minimum Bachelor degree in life science, regulatory science, or related field.
• Five (5)+ years in pharma/biopharma/contract research organization (CRO) regulatory, with a minimum of two (2) years Regulatory Project Management experience.
• Project Management knowledge and Certification is preferred.
• Strong knowledge-base of eCTD requirements, ICH guidelines, and FDA guidance documents.
• Experience working in global environment in interdisciplinary teams strongly preferred.
• Knowledge and experience in the management of electronic regulatory documents using an electronic document management system (EDMS).
• Must be proficient in MS Office Suite.
• Experience with Veeva Vault highly desirable.
• Experience with drugs/biologics therapy is preferred.

Nice-to-haves

• Good understanding of the regulatory environment and the current and emerging trends, policies, and best practices, and potential impact to projects.
• Ability to conduct regulatory research and analysis to identify and assess the regulatory requirements, opportunities, and risks for products and markets.
• Ability to provide regulatory guidance and advice to the project team and other stakeholders, and support the development and implementation of regulatory strategies and plans.
• Strong organization and time management skills, an ability to work on multiple projects simultaneously, and excellent attention to detail.
• Ability to understand and execute on the company's mission and values.
• Strong personal leadership and self-direction.
• Clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders across interdisciplinary teams.
• Exhibition of the highest degree of ethical standards and trustworthiness.