CMC Regulatory Affairs Advisor – 6 Month Contract – Home or Office Based: - Ireland
This is an exciting time for Acorn Regulatory. We are working with a diverse range of regulatory and pharmacovigilance clients all over the world. We have a large team of consultants based in Ireland and at sites across the world. Now we are recruiting for a Regulatory Affairs Advisor to work with our CMC team on a 6 month contract. This role can be home based (or you could choose to be based at our Irish offices.
Responsibilities of the Regulatory Affairs Advisor:
- Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
- Maintenance of marketing authorisations for nominated client via a range of regulatory activities including submission of variation applications and MA renewals.
- Communication with the appropriate competent authority to answer questions and obtain timely approval for changes.
- Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed.
- Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management in line with regulatory requirements.
- Maintain sound knowledge of European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to client products.
- Provision of guidance/technical support in the preparation of EU CTD dossiers applications.
- Builds and maintains strong relationships with different Competent Authorities to ensure ease of access and influence.
- Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company.
- Support other team members with the maintenance of the Acorn Quality Management System and ISO 9001, including generation and review of SOPs, reports and other quality documentation.
- BSc. Minimum or pharmacy primary degree.
- Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry.
- Experience with electronic submissions desirable
- Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
- Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets.
- Experience in the management of DCP’s, Centralised or other European procedures
- Excellent written and oral communication skills.
- Ability to project manage across a diverse and complex portfolio of products and priorities.
- Ability to get on with people, to influence people both internally and externally and to achieve objectives.
- Above average attention to detail and solid interpersonal, communication and organisational skills required.
- Excellent attention to detail with Client Care an integral part of your work ethic.
- Confidentiality and discretion.
- Motivated self-starter.
- Ability and desire to progress and represent Acorn Regulatory in an exemplary manner.