Regulatory Affairs Manager - Outside IR35

Job title - Regulatory Affairs Manager; Pharmaceutical

Location - London; Hybrid Working (3 days onsite, 2 days WFH)

Contract details -

Outside IR35; 12 month contract - £400 - 500 per day depedent on experience

Company details - Globally leading pharmaceutical company

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• Deliver and maintain competitive licences for UK including driving regulatory strategy for new initiatives. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership.
• Timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK achieved through provision of local regulatory expertise.
• Support the development of investigational and in-licensed/ co-development products through valued contributions to large scale projects, study feasibility questionnaires, scientific advice meetings and other related activities.
• Full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other company policies and Standards.

Key tasks relating to above job role purposes:

Generate Competitive Licences:

• Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
• Develop professional working relationships with assessors and administrative staff within the regulatory agencies

• Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications)
• Defend existing labelling and provide regulatory input into patent defence strategies

Regulatory Compliance and Governance:

• Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements
• Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to
• Provide regulatory input/solutions to supply and stock issues
• Liaise with Operations to manage pack changes and ensure labelling compliance

Commercial Support:

• Deliver the commercial objectives, including representing Regulatory Affairs on teams as appropriate
• Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
• Provide strategic regulatory input relating to the company and cornerstone brands, including competitor intelligence
• Project manage and deliver projects of commercial strategic value

Influence Regulatory Strategy:

• Ensure focused regulatory input into new product development via MC3 in the UK/EU business interest
• Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues
• Ensure appropriate cross functional input into the delivery of optimal licence strategies

Lead organisation and improve productivity:

• Ensure optimal departmental processes through continuous review
• Actively contribute to the development, coaching and training of the department, including new starters
• Support Regulatory Affairs Lead with department recruitment when required
• Consistently constructive, contributing, adaptable member of the department.

Candidate profile and experience

• 4+ years experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company.
• Life Sciences Degree or appropriate professional qualifications
• Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
• Demonstrable negotiation skills
• Ability to make optimal use of IT systems
• Therapy Area Expertise in one of the following diseases or technology areas: Respiratory, Cardiovascular, Diabetes, Renal, Oncology, injectable biologics, inhaled medicines, medical devices

This role does not offer sponsorship.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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