Regulatory Affairs Specialist
Sinclair
- Chester
- Permanent
- Full-time
✅ Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact
✅ Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
✅ One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way✅ Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleaguesWhat You'll Be Doing:
- To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines, specifically for EU/CEE markets, for Sinclair products.
- Communicate to management any changes in regulations or requirements that have been identified
- Undertake the preparation and submission of all new regulatory applications (e.g. clinical trials, registrations, renewals, variations, labelling / artwork) to agreed timelines
- Ensure all authorizations / registrations related to established products are maintained
- Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations
- Interact with regulatory consultants, regulatory and trade associates and other third-party service providers to ensure their provision of any requested activities to agreed timescales
- To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities
- Review and approve product artworks
- Maintain all submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information
- Identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
- Liaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessary
- Maintain monthly business reports as necessary
- Raise purchase orders as necessary and manage invoices related to assigned work.
- Assist in maintenance of tracking spreadsheets of costs for budgeting purposes.
- Organise consular services and translation services.
- Provide technical / regulatory input to Change Control Regulatory Assessments (EU/CEE) and associated RCN / RFRI.
- Work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions
- University Degree in a scientific or engineering field, desirable but not essential.
- 3-5 years’ experience in Regulatory Affairs
- Good in written and spoken English and regional languages as applicable.
- Knowledge of Regulatory legislation and guidelines for medical devices.
- Excellent computer and administration skills.
- Experience of working in an office environment and with both internal and external suppliers/customers.
- Specific knowledge in dermatology/aesthetics
- Working knowledge of Pharmaceutical and Biologic Regulations
- Performance-driven critical thinker
- Strong business acumen
- Ability to coordinate and prioritize multiple demanding tasks in a fast-paced environment.
- Ability to work effectively in a team environment and build strong working relationships
- Well-organised, target-orientated and flexible.
- Ability to work under pressure to tight deadlines in a multidisciplinary environment.
- Ability to complete work with minimal supervision.
- Strong written and oral communication skills.
- Management of confidential information.
- Excellent attention to detail when reviewing and preparing documentation.
- Ability to support project teams and management
- Establish and maintain relationships with local affiliates and partners
- Orientation towards achievement
- Adaptability and openness to change
- Ability to mentor and learn
- Integrity and professional ethics
- Cross-disciplinary cooperation