An innovative global pharmaceutical company, based in Cambridge, is currently looking for a Regulatory Affairs Manager to join their team on an initial 12-month contract. The role is currently offering remote working.
Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that regulatory deadlines and approvals are achieved. You will be working in a fast paced environment, so you must be able to work to deadlines and demonstrate a high attention to detail and full knowledge of the regulatory framework and process.
Other responsibilities include:
* Manage the full regulatory process
* Working with marketed products
* You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
* Contributing regulatory guidance in order to enhance product development
* Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements
* Acting as a point of contact between the company and regulatory agencies
* Previous experience in EU Regulatory Affairs and Compliance particularly within pharmaceutical industry
* Proven 360 regulatory affairs experience, including development, licencing and scientific advisory within a centralised environment
* Strong strategic experience within Regulatory Affairs
* EMA experience, working with marketed products or early development
* National and VHP EU clinical trials
* Exposure of Regulatory Affairs legislation and procedures
* Inflammation/Cardiology therapy experience
* Strong communication and interpersonal skills
* Demonstrable ability to work in a fast paced environment
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role