A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a GxP Auditor. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
Job Responsibilities:
- Effectively manage/execute/oversee the preparation of regulatory submission documents demonstrated by a deep knowledge of applicable legislation and guidelines for submission to government agencies and continued client compliance.
- Facilitate submission approvals and amendments through leading communications (face to face meetings, teleconferences, etc.) and negotiations with client, government agencies, and project teams.
- Build positive working relationships with clients, and government agency contacts.
- Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required.
- Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Responsible for managing workflow including prioritising project objectives and establishing timeframes for projects with clients.
- Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Lead, participate in, and support project teams, and advise other departments on regulatory issues and strategies related to EU filings and maintenance activities across a broad range of product types.
- Effectively prioritise and complete multiple projects within established timeframes and within budget.
- Train, coach, and develop assigned individuals to build team expertise across various product types (preparation of files, regulatory strategy, client management, agency/client communications and project management).
- Enthusiastically monitors for new regulatory requirements and shares key findings.
- Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
- Publish and/or present at training seminars or lead workshops at industry conferences.
- Participate actively in other business-related projects (business opportunities, client specific issues etc.).
Skills and Requirements:
- A minimum of a bachelor's degree is required. Master's degree in a scientific or health-related field preferred.
- Minimum of 7 years of Quality experience in the biotechnology or pharmaceutical industries required.
- Certified Quality auditor.
- At least 5 Years of Quality auditing experience, with 10 being ideal.
- In depth knowledge of GDP, GMP.
- 5 Years of Experience in Regulatory inspections management.
- 2 years of International travel.
- Working knowledge of PV, Medical Device and Food Supplement requirements.
- Experience of audits in all GxP.
- Experience in auditing sterile manufacture.
- Experience in microbiology.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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