Regulatory Affairs CMC Manager – Clonmel or Dublin based - Ireland
Acorn Regulatory is growing at a fast pace. We have recently recruited a number of new staff members for our Clonmel facility. We are now recruiting for a Regulatory Affairs CMC Manager to be based in either Clonmel or in our new Dublin office.
Our company works with a global client base and offers candidates the opportunity to work on a wide variety of projects. Right now, we are working with 7 of the world’s top 10 pharmaceutical companies, 6 of the world’s top 10 medical device companies and a large number of dynamic healthcare companies that are based all over the world.
As part of the ongoing expansion at the company, we are seeking to recruit a suitable individual for the role listed above. If you are interested in the role then you should send a CV and a covering letter to Brian Cleary, Acorn Regulatory, Suite 6 Powerstown House, Gurtnafleur Business Park, Clonmel, Co. Tipperary or you can email: firstname.lastname@example.org . Please state if you wish to be based in Clonmel or Dublin when submitting your application.
The details of the role are:
• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
• Review the preparation of CMC components for filings and assess fitness of purpose for submission in the relevant countries
• Gathering, consolidating and analyzing regulatory intelligence for the EU & ROW territories and support its application to product-specific activities
• Ownership/ regulatory responsibility for a portfolio of products for nominated client; via a range of regulatory activities including submission of new marketing authorization applications, variation applications and renewals.
• Work with the Managing Director and Project Manager to ensure that client deadlines are met and that appropriate resources are allocated to the various projects
• Maintain communication with client and Acorn Regulatory teams to ensure that projects are delivered in keeping with our responsibilities to the client.
• Builds and maintains strong relationships with EU competent authorities to ensure ease of access & influence.
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to the company’s products.
• Supports EU regulatory initiatives and issues as appropriate.
Knowledge and Skills
• BSc (MSc or higher preferred) life sciences, or related field
• 7-10 years related experience within Pharmaceutical Regulatory Affairs
• Experience with global legislation and regulations relating to medicinal product registration
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, line extensions and renewals.
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Ability to project manage across a diverse and complex portfolio of products and priorities.
Contact Brian Cleary if you would like to apply for this role by emailing him at the email address listed above.
Acorn Regulatory will not be dealing with recruitment agencies at this time.