Sr. Associate, Regulatory Affairs CMCLocation Cork, Ireland
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.
Regulatory Affairs CMC Senior Associate support the Regulatory Affairs CMC Product Lead to ensure the activities and the documentation, align with the global regulatory strategy in order tocomply with the necessary regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics to fulfil project objectives.
- Conduct relevant checks to support regulatory cmc queries from various groups across site,
- Process Quality (CMC) and GMP documentation to support global submissions.
- Responsible for the timely sourcing and or authoring of documentation to support regulatory submissions worldwide
- Assist in the preparation for interactions with global regulatory authorities
- Represent regulatory cmc at relevant site meetings
- Participate in global teams as regulatory cmc representative for project specific discussions
- Responsible for timely sourcing and or authoring of documentation to support regulatory filings and/or correspondence with Regulatory bodies.
- Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
- Ensure consistent and appropriate communication within the department and with other functional areas.
- Interact with global Regulatory partners, internal cross functional teams, and consultants.
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- Lead specific CMC submissions in collaboration with Regulatory CMC Product lead and subject matter experts.
- 5+ years experience in a cGMP regulated environment, with exhibited knowledge or proficiency in CMC Regulatory Affairs or a related function.
- Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
- Demonstrated effective problem solving, strong understanding of regulatory affairs submission and management skills and the ability to prioritize multiple tasks are also required
- Ability to comprehend scientific and health authority information related global drug development guidelines and regulations.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations. Rest of world experience, 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.