Regulatory /Quality & Compliance Manager

CPL

Dublin, Dublin West

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory /Medical Affairs/ Quality and Compliance Manager to join their local commercial affiliate. The candidate will be responsible for supporting the commercial team in achieving business objectives by managing regulatory approvals and ensuring the compliance of the company and their products with local regulations and internal procedures. This role has line management responsibility for a Regulatory / Quality and Compliance Assistant. The role reports to The General Manager, Ireland. Responsibilities: Manage and implement all regulatory and medical affairs projects for the Irish affiliate for marketed and non-marketed products in a timely manner, i.e. license maintenance, lifecycle management, new market authorisation applications and the submission and approval of variations, renewals, PSURs. Manage and oversee regulatory strategies and the preparation of regulatory documents targeted for the Irish Market within required timelines. Manage regulatory files for Malta Oversight : Oversee the review and approve regulatory documents (SPCs, PIL and labelling) and implementation of approved artwork/packaging in line with regulations. Manage all regulatory aspects for new product launches. Manage relationships with HCP’s in future therapy areas (i.e.: pre-launch phase. Prepare regulatory strategies and contribute to business decision making in relation to product launches and product changes Oversight : Oversee the management and approval of promotional material and advertising. Preparation and submission of product price applications Oversight : Oversee the management of training internally – preparation and delivery of training on relevant scientific and regulatory topics. Lead investigation in potential non-compliance issues and coordinate with relevant stakeholders and colleagues as necessary. Regulatory surveillance and update of affiliate teams of new or topical issues for consideration Oversight : Oversee the management of medical information queries from the marketplace and the provision of timely, scientific responses to enquirers. Act as back-up for pharmacovigilance and quality (product complaints, recalls etc) within the company. Work collaboratively with relevant Global and country teams to establish and implement regulatory strategies within agreed timescales. Advise the local teams on regulatory updates, when required. Management and approval of promotional material and advertising. Interface and liaise with relevant government agencies (e.g. HPRA, HSE) as required to ensure that the company is in compliance with all regulations and laws in relation to products, packaging, production, marketing and advertising. Oversight : oversee the management of quality and compliance issues including : Management of complaints, recalls/mock recalls, deviations, returns, change control; management of medical information/PV handling and reporting. Candidate Profile: BSc in science / life sciences degree. Minimum of 3 years’ experience in a regulatory affairs role. Knowledge and experience of current EU registration and dossier requirements. Excellent verbal and written communication skills. Results and performance driven – deliver results that meet or exceed expectations. Sense of urgency – responding to issues and opportunities in a timely manner. Take ownership and accountability for activities. Ability to lead and support several concurrent projects/products. Team player with Positive ‘can – do’ attitude. Be able to work autonomously and have good problem-solving skills. Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business. Ability to influence and partner with cross-site teams in a global pharmaceutical organisation. Execution – persistent drive for results utilising sound project focus, organisational and problem-solving skills. Enthusiasm and Drive to take complete ownership and drive process improvement initiatives. Occasional travel is part of the job. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. #THR2018. This job originally appeared on RecruitIreland.com.

1915 days ago