As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
location: San Rafael, California
job type: Contract
salary: $59.50 - 70.00 per hour
work hours: 9 to 5
Global Regulatory Affairs is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. Regulatory Affairs serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of Regulatory Affairs to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The Regulatory Affairs department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
As part of the Regulatory Affairs department, the Regulatory Project Management (RegPM) team is responsible for ensuring regulatory strategies are translated into realistic and achievable submission plans and that Global Regulatory Team operations are driven by effective application of project management expertise.
Project Manager 1/2 supports and drives the efficiency and effectiveness of the Global Regulatory Team, Regulatory Strategy Meetings, and Regulatory or cross-functional sub-teams such as Health Authority meeting teams or Marketing Application/Investigational New Drug/Clinical Trial Application filing teams, as appropriate, in partnership with the Global Regulatory Lead or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.
•Decision Making and Problem Solving, such as analyzing, evaluating, and suggesting possible solutions to problems consistent with procedures and within sphere of influence
•Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating an understanding of organizational structure, key decision-making processes and governance and communication channels
•Agility and Proactivity, such as skill in inspiring, motivating and empowering employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
•Leadership, such as taking accountability for own team assignments and proactively offering support to team members and team leaders when appropriate
•Communication, such as developing and delivering well organized and effective presentations
•Strategic Thinking and Planning, including demonstrating an understanding of Global Regulatory and BioMarin strategic objectives
•Project Management, such as demonstrating a basic understanding and use of project management principles, tools, and techniques, including MS Project
•Team and Stakeholder Management and Communication, including an ability to leverage relationships to influence timelines and project management outcomes across the business
•Drug Development and Product Knowledge, including understanding the objectives/purpose of each clinical trial phase
•Regulatory Guidances and Processes, such as having a comprehensive understanding of the regulatory pathways, including when and how to file for designation, the time points and opportunities for interaction, and the resources required
•Process Improvement, including an ability to effectively leverage data for process improvement using an extensive knowledge of data and statistical analysis and able to clearly communicate results and implications
Education & Qualifications:
•Bachelor's degree in health or life sciences
•4+ years experience with bachelor's degree
•Project Management experience in Biotech/Pharmaceutical company preferred
•Regulatory Affairs experience in Biotech/Pharmaceutical company preferred
•MS Project experience (or other project planning software) preferred
•Proficiency in MS Office suite, including Outlook, Word, and PowerPoint, and Excel required
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.