A Regulatory Specialist is required for a Cork based multinational biotech manufacturer. This is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
As Regulatory Affairs Specialist you will report to the Regulatory Affairs Sr. Manager, and be responsible for supporting operations and assisting with regulatory filings and correspondence with Regulatory bodies.
o Support the timely compilation of site documentation for global regulatory CMC submissions.
o Co-ordinate requests for legalization of GMP documents.
o Interact with global Regulatory partners, internal cross functional teams, and consultants.
o Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
o Ensure consistent and appropriate communication within the department and with other functional areas.
o Assist in the preparation for on-site inspections by global regulatory authorities.
o Participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
EDUCATION AND QUALIFICATIONS:
o Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
o Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
o Demonstrated effective problem solving, strong time management skills and the ability to prioritize multiple tasks are also required.
o Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
For full details on this role please contact Kathy or apply directly through this advert.