Regulatory Specialist

Claran Consultants

Cork

Regulatory Specialist is responsible for supporting operations and assisting with regulatory filings and correspondence with Regulatory bodies. Required for a leading Bio facility in Cork. Initially a 23 month contract. Contact Ann 021 4701100 or email ann.laide@claran.ie. Role. Support the timely compilation of site documentation for global regulatory CMC submissions. Co-ordinate requests for legalization of GMP documents. Interact with global Regulatory partners, internal cross functional teams, and consultants. Proactively identifying issues and suggesting appropriate strategies to mitigate risks. Ensure consistent and appropriate communication within the department and with other functional areas. Assist in the preparation for on-site inspections by global regulatory authorities. Participate in cross-functional project teams and work effectively with multiple disciplines and personalities. Education. Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required. Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure. Demonstrated effective problem solving, strong time management skills and the ability to prioritize multiple tasks are also required. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. This job originally appeared on RecruitIreland.com.

2617 days ago