Senior Manager Medical & Regulatory Affairs

A hybrid role, this position is ideal for an ambitious Medical Affairs professional wanting to join a growing organisation with real vision.
The role is multi faceted and is one that will provide leadership to an established & talented Medical Affairs and RA group.
Operating in both a strategic and operational fashion this role will lead & participate in the development and implementation of short- and long-term Medical & Regulatory Affairs strategies & is responsible for the execution in delivery of regulatory milestones.
Is responsible for developing UK Regulatory & Medical Affairs new product (pharmaceutical, medical device) / service launch strategy to ensure regulatory compliance through collaborative working with Sales & Marketing and Market Access Leadership.
Will act as a Medical Signatory for the organisation in accordance with the ABHI/ABPI Code of Practice in order to approve promotional materials for pharmaceutical products in the UK.
You will be used to tracking regulations and government / healthcare policies regarding medicines, medical devices including software as a medical device & AI, biocides and cosmetics and patient services.
Maintain extensive clinical/scientific expertise as a subject matter expert of the relevant therapeutic areas, products, company pipeline, medical technology and competitors.
Build capabilities, plans and systematic tracking of impactful Medical Affairs activities.
To act as the Clinical Safety Officer (CSO) for current and emerging digital technologies and be responsible for providing leadership, guidance and specialist knowledge including clinical safety reviews, approval of new digital solutions, upgrades to existing marketed digital solutions etc.
To lead and or support with MHRA or other regulatory agencies .
Other Key Responsibilities and Duties:
To ensure that the long-term strategic objectives of the UK Regulatory Affairs department are achieved.
To Lead in the strategic digital portfolio planning for company digital technologies, ensuring that there is a clear relationship between the Clinical Risk Management Strategy and the Digital Strategy
Responsible for analysing and investigating complex and inter-linked digital and clinical issues in relation to digital clinical safety
To develop and maintain strong internal and external relationships with regulatory, NHS partners and key opinion leaders to support in the delivery of regulatory and business development strategies.
Oversee /Manage multiple concurrent strategic product and service development projects of various sizes and timescales across the business.
Qualifications & Experience
You will be a qualified Pharmacist and ideally a GMC registered MD and be someone who will act as the ABPI medical signatory.
You will be well versed in leading a team in a Medical/Clinical Research Department in a Pharmaceutical or Medical Device company or NHS (pharmacy/clinical/intensive care) and have knowledge of NHS and Health Economics.
Knowledge of current regulations governing sale and supply of medicines, medical devices (including ABPI code) and ideally biocides and cosmetics.
Experience in the development and licensing of medical devices.

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