AX 5117 CMC Project Manager

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Category: Regulatory Affairs Location: Berkshire , United Kingdom Job Reference: AX 5117 Job Type: Permanent Package details: Competitive Benefits Package

JOB SUMMARY:

Permanent position for a CMC Project Manager to work within this renowned Global Pharmaceutical Company. Responsibilities include: product registration, submissions, representing Regulatory cross functionally, coordinate affiliates and ensuring compliance across life cycle. The role has strategic elements and will see you mentor and train team members.

BACKGROUND:

Broad based Global Pharmaceutical Company

EU HQ based in M4 / M40 Corridor

Very respectful pipeline – incl blockbuster

Office Based role / full time.

PRIMARY DUTIES:

Provide strategic input into the development of assigned projects handling complex issues, seeking guidance where appropriate. Ensure input from sub-team members and issue international regulatory plans as appropriate.

Attendance at project teams (Brand teams, Product Workstreams, CMC Workstreams etc.) and sub-team meetings, representing EPD RA as appropriate.

Prepare regulatory filings for submission to international regulatory agencies. Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across geographic areas.

Coordinate assigned affiliate(s) workload planning & prioritisation and performance. Monitor actual vs. planned activities and timelines. Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression

Prepare and present written and oral reports and other presentations to team members and other internal audiences. Adjusts presentation style and content to suit the audience. Manage the preparation and review of technical strategic regulatory documentation for agency submission. Responsible for ensuring accuracy and quality of documentation.

Manage projects (Brand team or Product/CMC Workstream) within one or more therapeutic areas.

Maintain geographic intelligence, liaison and affiliate support for specified countries as provided by manager. Manager provides project assignments and strategic direction.

Resolution, Prediction of regulatory issues. Anticipate future problems, resolve current issues. Learns and adjusts based on prior results. Maintain awareness of new draft legislation and guidelines.

QUALIFICATIONS / EXPERIENCE REQUIRED:

Life Science Degree and relevant CMC Regulatory Affairs experience.

You will need to be at a level to mentor other staff and provide strategic direction on projects.

KEYWORDS:

CMC Project Manager / Regulatory Affairs Project Manager / CMC / cmc / cmc project manager manager / Bucks / Berks / CMC PROJECT MANAGER / M4 M40 Corridor

TO APPLY:

For a confidential discussion please telephone Omar de Bary at AXESS Limited on 020 8560 2300 or, click on “apply now” below, to submit your details.

Only candidates with EU work authorisation will be considered.

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk