Regulatory Affairs Project Manager
|Job Title:||Regulatory Affairs Project Manager|
|Location:||San Francisco Bay Area|
|Contact Name:||Scott Cook|
|Job Published:||October 21, 2020 19:22|
SciPro are supporting a key CDMO client based in the San Francisco Bay Area as they look to hire a Regulatory Affairs Project Manager. This role will be responsible for total project management and delivery of complex research, development, and production projects from the proposal stage through to successful project completion, in close collaboration with clients, partners, internal business units, and other key stakeholders.
The ideal candidate will have proven expertise in authoring key sections for IND Submissions and will have worked with have preferably worked with Clinical and Commercial Biologic Products.
An ability to speak both English and Mandarin would be highly advantageous but is not a strict requirement.
Duties and Responsibilities:
- Leads cross-functional project coordination with technical, engineering, production, facility, quality, business development, marketing, and other related business units, and manages overall integration of project activities to complete projects on time, within budget, to specifications, and with accuracy and efficiency.
- Establishes project goals within broad outlines provided by top management, directs project design, outlines and delegates tasks involved, and reports progress to all key stakeholders.
- Develops and implements policies, standards, and procedures for project management.
- Assesses project feasibility by analyzing technology, resource needs, and market demand; investigates project challenges; implements corrective measures; evaluates results; and makes recommendations for future improvement.
- Conducts cost analysis, estimating expected costs for projects.
- Recommends, prepares, and implements project budgets, bids, and contracts based on estimates.
- Acts as a liaison between the Company, partners, clients, and vendors; manages day-to-day, real-time communications and expectations to all stakeholders; and cultivates client relationships.
- Organizes project meetings, prepares agenda and minutes, and follows up on action items.
- Consults and negotiates with clients to prepare project specifications.
- Presents and explain proposals, reports, or findings to clients.
- Addresses questions, concerns, and complaints throughout projects.
- Ensures compliance with federal, state, local, industry, contractual, and Company regulations, standards, specifications, and best practices.
- Performs other duties as assigned.
- Bachelor’s degree in Biological Sciences, Chemistry or related, or equivalent experience.
- 5+ years’ relevant biotech and/or pharmaceutical industry experience in Chemistry, Manufacturing, and Controls (CMC) process development and current Good Manufacturing Practice (cGMP) manufacturing.
- 5+ years’ experience in project management or external research collaboration management of biological molecules.
- Experience in managing multiple complex projects and total project delivery in a cGMP manufacturing environment.
- Experience in a Contract Manufacturing Organization (CMO) or Contract Research Organization (CRO).
- Experience in technical transfer.
- Understanding of the functional requirements of pharmaceutical facilities and technical, engineering, and manufacturing best practices.
- Understanding of federal, state, local, and industry, cGMP, regulatory, environmental, and safety, federal, state, local, industry, regulatory, environmental, and safety regulations,
- Hands-on client experience, including negotiation and management of bids, contracts, and agreements.
- Excellent presentation and verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills, attention to detail, and ability to maintain a high level of accuracy.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to work independently and collaborate as part of a cross-functional team.
- Thorough understanding of or the ability to quickly learn about the project or product being developed.
- Proficient with Microsoft Office Suite (Excel, Outlook, Word, and PowerPoint), Enterprise resource planning (ERP), and project management software.
- Equivalent education and experience may substitute for stated requirements.
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