Regulatory Affairs Associate Manager
5 hours ago
QbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD.
Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). We are looking for an (Associate) Director Regulatory Affairs Pharma to join our UK team.
What do we expect from you as (Associate) Director Regulatory Affairs Pharma ?
You provide a full range of regulatory consulting services (strategy and writing) with an emphasis on clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
You deliver complex projects on time and to a high quality.
You are a source of regulatory expertise in the development, registration and post-licensing activities of pharmaceutical products.
You have line management responsibility and provide guidance to the international QbD team across projects (training, supervising, mentoring, reviewing).
You continue to build a network of industry colleagues. You develop and maintain personal contacts with regulatory agencies or professional associations to build confidence in and enhance the reputation of QbD Group.
You assist in the preparation of proposals (e.g. researching new potential projects, determining activities required).
You are able to commute to our headquarters in Chalgrove (Oxford area) for onsite working 2 days per week.
You have sound knowledge of European pharmaceutical regulations and guidelines.
You have significant regulatory affairs experience including a successful track record in the development, registration and life-cycle maintenance of medicinal products within Europe, in particular a strong background in the review/generation of clinical documents (overviews, briefing packages, orphan drug designations, paediatric investigation plans).
You can establish strong connections with clients, regulators, management and colleagues.
A true QbD’er can be recognized by the following qualities:
~ Resilient : Your strong and positive attitude helps you overcome any challenge
~ QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations.
As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development.
Moreover, we aim to create a joyful community where you dare to be and can be yourself.
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