Job Description

Salary: \xc2\xa370 - \xc2\xa380 per hour

• Job type:

Contract * Discipline:
Project Manager * Location:
United Kingdom

London, England

Posting date: 26 Jun 2023

Reference: 55051

Proclinical are recruiting a Senior Regulatory Affairs Manager for a biotech organisation. This role is on a contract basis and with the ability to work remotely within the UK.

Responsibilities:

• Predict the likelihood of regulatory success and timelines based on suggested methods.
• Uphold a consciousness of new and developing legislation, regulatory policy and technical regulatory direction linking to the company\'s products, and review and discuss the impact.
• Outline and advise the GRT on regional considerations in developing creative regulatory method.
• Guarantee European regional requirements are well outlined and executed in cooperation with pertinent regional shareholders.
• Arrange and offer leadership to company responses to requests from regulatory authorities such as response to questions.
• Serve as the main point of contact and produce relationships with agency personnel on specific product assignment and document and discuss details and results of regulatory agency interactions.
• Discuss and guarantee alignment with suggested regulatory methods such that expectations, regulatory risks, and mitigations are characterised and comprehended.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Familiarity in a therapeutic area European regulatory affairs lead role, outlining and executing regulatory methods and implementational plans.
• Expertise on regulatory regional legislation.
• Acquaintance working with policies, procedures, and SOPs.
• Past involvement in national legislation and regional guidelines linking to medicinal products.
• Comprehension of the regional regulatory processes for CTAs, Mas, post approval changes, extensions and renewals.
• Comprehension of drug development.
• Know-how of and familiarity within a regional regulatory setting in pertinent product area and development stage.
• Comprehension of regulatory actions, touch points and how they affect projects and procedures.
• Acquaintance working with the EMA and centralised process.
• Past involvement in Inflammation, Cardiovascular, Bone, Therapeutic Area, etc.
• Former involvement working with biotech products.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.

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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#Regulatory

Proclinical