Project Manager, Regulatory Affairs

Location:  San Rafael, California Category: Regulatory

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

Our Regulatory Affairs organization, made up of a team of over 100 dedicated professionals, continues to grow. If you are an experienced Project Manager with knowledge of drug development and/or marketed products, interested in working in an environment where you’ll have the resources and infrastructure to tangibly impact patients’ lives, we want to talk with you. 

RESPONSIBILITIES

·        Manage Regulatory Global team operations, including facilitation of Sub-team and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required)

·        Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management

·        Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities

·        Document project milestones/deliverables and report progress against team, department and corporate goals

·        Facilitate short and long-term planning activities

·        Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement

 

EXPERIENCE

Required Skills:

·        At least 5 years’ experience in a project management or scheduling environment; a minimum of two years’ experience managing teams and team operations

·        Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology

·        Pharma/biotech or related industry experience required

·        Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others

 

Desired Skills:

·        Exposure to electronic document management system(s) (EDMS) helpful

·        MS Project Server experience helpful

·        Knowledge of Regulatory Affairs submissions and nomenclature required

·        Experience managing data within product registration tracking system(s) desirable

 

EDUCATION

Bachelor’s degree desirable.



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.