LD6944 / Our client are currently looking to recruit a Director of Regulatory Affairs.
Role Responsibility
To provide strategic Regulatory Affairs input and effective Regulatory Affairs oversight to projects being undertaken by the Company in accordance with Company Policy, Standards and Procedures at all times to actively promote the best interests and development of the company.
Additional Responsibilities:
• Member of the EU & APAC Regulatory Affairs Leadership team and contribute to the provision of strategic direction and management of the EU & APAC Regulatory Affairs Group
•Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs and Drug Development Consulting for (Bio-) Pharmaceuticals, Foods and Cosmetics, and Medical Devices
•Director RA may work either alone or as part of a team depending on the size and nature of project and may act as Project Manager as designated by the Vice President/Senior Director
•When the Director RA acts as Project manager, s/he is accountable for all matters relating to that project and for communication with the client
•Provide oversight for major regulatory submissions and perform high-level review and sign-off authorisation of regulatory submissions, as required
•Provide internal support regarding regulatory aspects of individual clinical protocols through to all aspects of full development programs
•Support Business Development in preparation of proposals and bids and act as client liaison, when required
•Director RA is expected to maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses
•Undertake other reasonably related duties as assigned by management
Experience and Qualification
•To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
•A degree or equivalent in an appropriate discipline, for example Life Sciences, Pharmacy, Chemistry, Medicine, Veterinary Medicine.
•Extensive experience in the pharmaceutical or pharmaceutical contract service industry or other appropriate experience
•Demonstrable experience with regulatory submissions (IMPD/IND, MAA/NDA), product development and strategic liaison with a range of Regulatory Authorities
•Excellent written and verbal communication skills, management and leadership skills, as well as demonstrated problem-solving ability, strong interpersonal skills and the ability to plan-organise. •Demonstrable supervisory/management experience
•Travel (approximately 25%) domestic and/or international
For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.