GMP Coordinator

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.

Responsibilities:

• Support regional leads and local teams with the coordination, communication, planning, preparation and submission of site GMP and compliance-related content pertaining to Marketing Application(s) and Establishment Licenses for initial/renewal applications in Global markets aligned with regulatory strategy.
• Be the point of contact between Local Regulatory Teams and SMEs/CMOs to support GMP/site registration submissions.
• Coordinate Power of Attorney and other signature/legalization process  

Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.

• Support regional leads and local teams with the creation of timelines and tracking deliverables to timelines to ensure timeline submissions aligned with program milestones.
• Update relevant dashboards on progress of regulatory document preparations working closely with Regulatory and Quality partners
• Ensuring consistent and appropriate communication within the department and with other functional areas.
• Interfacing with global Regulatory partners, internal cross functional teams, and consultants.
• Attending relevant functional area and project team meetings
• Process documentation requests to support key application activities
• Assisting in the timely preparation for interactions with global regulatory authorities.
• Initiate request for Agency issued documentation (e.g. FDA Certificates of Pharmaceutical Product, Site Manufacturing Licenses), notarization, and legalization, when applicable. 
• Maintain system for Regulatory CPP/CMP and Document Authentication Requests 
• Track GMP / site registration renewal timeline together with local teams

Education:

• BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.

Experience:

• At least 2 years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global Pharmaceutical and/or Biotechnology Company (preferably with exposure to both development and commercial phases of product lifecycle).
• Outstanding interpersonal and communication (written and verbal) skills is required.
• Strong writing and editing skills for technical documentation.
• Project management skills are a plus.
• Proficient with computer and standard software programs.
• Ability to work across the Global time zones

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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