Regulatory Senior Project Manager

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n San Rafaeln

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n BioMarin Pharmaceuticaln

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Regulatory Senior Project Manager

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Location: San Rafael, United States

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Apply

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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About Worldwide Research and Development

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From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

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As part of the Global Regulatory Affairs & Patient Safety (GRAPS) department, the Regulatory Senior Project Manager supports and drives the efficiency and effectiveness of regulatory or cross-functional sub-teams in partnership with the Global Regulatory Lead (GRL) or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.xc2xa0xc2xa0

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PM responsibilities may include:

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Strategy and Executionxc2xa0

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• Contribute to and support global regulatory strategies and operations, ensuring that they align with program goals/objectives and input of the GRT with functional regulatory representativesxc2xa0xc2xa0 n

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• Track and drive for action item completionxc2xa0 n

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• Partner with GRL and functional regulatory leads to prioritize team activities and manage competing prioritiesxc2xa0 n

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• Develop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders; maintain timelines from pre-clinical phase through product life cyclexc2xa0 n

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• Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross functional dependencies n

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• Document regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as neededxc2xa0xc2xa0 n

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• Prepare project and cross-project dashboards for teams/management, highlighting key regulatory activity such as submission and approval milestones, review periods, etc.xc2xa0xc2xa0 n

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• Track regulatory submissions and approvals globally in the designated tracking system, if applicable for productxc2xa0 n

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• Track and monitor completion of commitments for duration of lifecycle maintenance and ensure timely status updates are made in the designated tracking system, if applicable for productxc2xa0 n

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• In partnership with Global Regulatory Lead (GRL), enforce guidelines of GRT Charter (or other relevant team charters)xc2xa0 n

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Meeting Management & Supportxc2xa0

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• Schedule GRT meetings, generate the agenda and facilitate the meeting (in collaboration with the GRL), and document/distribute minutes (including action items) according to GRT Meeting Best Practicesxc2xa0 n

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• Schedule Regulatory Advisory Boards (RABs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to RAB Charterxc2xa0 n

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• Provide high-level support to MA/IND/CTA Filing teams (and module teams as applicable)xc2xa0 n

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• For all other meetings (such as Advisory Committee, Paediatric Investigation Plan (PIP), or ad hoc), PM may document decisions and/or action items as neededxc2xa0 n

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Cross-functional Leadershipxc2xa0

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• Liaise across regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignmentxc2xa0 n

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• Communicate regulatory information and activities to stakeholders outside of regulatory and externallyxc2xa0 n

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• Partner with various stakeholders to transition products from development to marketed stagexc2xa0 n

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• Represent Regulatory on Production Integration Management Team (PRIME) and align on deliverables/timeline with cross-functional PMs; provide input on regulatory activities in the product dashboards created by the PRIME teamsxc2xa0 n

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• Identify and implement opportunities for process improvement within GRAPS n

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Competencies:

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• Decision Making and Problem Solving n
• Influence, Cross-Functional Collaboration and Organizational Awareness n
• Agility and Proactivity n
• Leadership n
• Communication n
• Strategic Thinking and Planning n
• Project Management n
• Team and Stakeholder Management and Communication n
• Drug Development and Product Knowledge n
• Regulatory Guidances and Processes n
• Process Improvement n

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Education & Experience:

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• Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred n
• 6+ years with Masters/MBA, 8+ with bachelorxe2x80x99s degree n
• Project Management in a Biotech or Pharmaceutical Company experience preferred n

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Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Ireland Safety Responsibility

Support the organisationxe2x80x99s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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