Regulatory Affairs Advisor (CMC) - Home based - 6 Month Contract

Recruiter
Acorn Regulatory
Location
Cardiff (Caerdydd)
Posted
04 Aug 2017
Expires
14 Aug 2017
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. T his role can be home based (and would suit someone living in the UK or elsewhere) or you could choose to base yourself 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. Qualifications/Minimum Required: (Education/Experience/Competencies) 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. Established in 2002 Acorn Regulatory has a global client base and works with 7 of the top 10 pharmaceutical companies, 6 of the top 10 medical device firms and a wide range of dynamic life science companies. If you would like to have an initial confidential conversation about this role then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706. This job was originally posted as www.totaljobs.com/job/75303077