Associate II, Regulatory CMC
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.
- Coordinating the planning, preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for US and Ex-US markets in accordance with the developed regulatory strategy.
- Collaborating with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
- Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
- Creating timelines and tracking deliverables to timelines to ensure timeline submissions aligned with program milestones.
- 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 preparation for interactions with global regulatory authorities.
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
- At least 3 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.
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.