Senior Manager, Regulatory Affairs Project Management

Recruiter
Axess Ltd
Location
Wiltshire
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Key position for a project management professional who has supported/managed regulatory submission operations combined with experience of managing or leading cross-functional project teams in a drug development company.

BACKGROUND

- International biopharmaceutical company
- Experiencing consistent growth with exciting pipeline
- Broad, varied role working with key stakeholders internationally
- This role will have broad project management responsibility with a focus being on the management of global expansion of regulatory submissions for global MAA.

PRIMARY DUTIES

A member of the Project Management department responsible for assisting in management of cross-functional drug development teams in a matrix organisation. Working closely with the Senior Director and Director of Project Management to ensure successful completion of project goals on schedule and within budget.

Key responsibilities include:

- Establishing and maintaining project plans and budgets
- Assist in management of cross-functional drug development project teams and sub-teams
- Organising and leading project team meetings
- Fostering communication and coordination between functional groups ensuring adequate resourcing to meet goals
- Identifying risks and mitigations and providing updates on project status to project team leaders.

QUALIFICATIONS / EXPERIENCE REQUIRED:

- Significant experience in project management (ideally within regulatory affairs or supporting regulatory affairs) including managing cross-functional project teams in a matrix organisation
- Ideally some exposure to Emerging Markets
- A comprehensive understanding of regulatory submission and dossier components/content
- Thorough understanding of the drug development processes
- Proven track record of success in Project Management with demonstrable, quantifiable outcomes/improvements
- Experience creating and actively managing integrated timelines and budgets

Education

- B.S. in a life science / pharmaceutical R&D/ engineering, or related technical field; Advanced degree (MS / PhD / Pharm D / MBA) or PMP Project Management Professional is a plus

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

Benefits:

Comprehensive

TO APPLY:

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-6980

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