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Regulatory Specialist (Temporary) - Ireland
Posted on : 26 February 2017
- 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.
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.