CMC Regulatory Affairs Associate
CK Group are recruiting for a CMC Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre ofDublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub innt(s) procurement, preparation and coordination. You will also serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
- Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products.
- Acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams
- The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site.
- The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.
- CMC- specific regulatory knowledge & experience
- Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience
For more information or to apply for this CMC Regulatory Affairs Associate position, please contact Natasha on +44 1438 870011 or email email@example.com, quoting job ref 49323.
It is essential that applicants hold entitlement to work in Ireland.