Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).

During the Graduate Programme, you will get the opportunity to work with a number of different teams giving you a broad range of experience. You will work closely with our experienced Regulatory Affairs team and get an understanding of how the Regulatory... Affairs function supports the business to deliver on our product and quality priorities. You will also have the opportunity to gain experience in new marketing authorisation applications, post approval variations, renewals, artwork updates and pharmacovigilance

Key Responsibilities (include but not limited to):
• Preparation and submission of documentation for variations, renewal and marketing authorisations under supervision to various Regulatory Authorities
• Draft Summary of Product Characteristics, Patient Information Leaflets and packaging for inclusion in regulatory submissions
• Reply to queries raised by Regulatory Authorities on submitted applications
• Work in conjunction with artwork team to ensure updated artwork is implemented in compliance with regulatory timelines for use in manufacturing
• Review and sign off on GMP site documents
• Review and assessment from Regulatory Affairs perspective of Change Controls and Deviations
• Adherence to site Quality Management System by complying with defined procedures

What the Graduate can expect in return:

During your two years on the Programme, you will gain insight into the challenges and opportunities facing our businesses and our people. You will have real responsibility and will play a key role in strategic projects and initiatives. You will work with and learn from great people and develop your technical expertise in Regulatory Affairs. You will be provided with a dedicated mentor throughout the programme and will be given the opportunity to network with other graduates in the South East Region.

The ideal candidate will have:
• Degree in Chemistry, Life Sciences or equivalent.
• Good problem solving skills
• Excellent interpersonal & communications skills
• Excellent planning and organisational skills
• Ability to work well within a team and on own initiatives
• Good project management experience
Waterford Ireland

Salary Criteria