Regulatory Specialist (Temporary) - Ireland
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- Our company 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.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology.
- Come join our team and make a meaningful impact on patients’ lives.
- We are 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 organizational skills.
- The Regulatory Affairs Specialist reports to the Regulatory Affairs Sr. Manager, and is responsible for supporting operations and assisting with regulatory filings and correspondence with Regulatory bodies.
- 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.
- 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.
- Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.