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Job Details

MANAGER, EMERGING MARKETS REGULATORY AFFAIRS - Spain, Italy, Germany, United Kingdom

Company: PRA Health Sciences
Location: Spain, Italy, Germany, United Kingdom
Reference: FC-2018-44456
Closing Date: 30 May 18
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

At PRA we know our greatest strength is our people. We have a commitment to employee development and a culture that values innovation. Where great minds work everything is possible.

Requirements:

MANAGER, EMERGING MARKETS REGULATORY AFFAIRS

Location: Spain, Italy, Germany, United Kingdom

Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

As a Manager of Global Regulatory Affairs, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.

Position overview:

The Manager of Emerging Markets Regulatory Affairs (EMRA) is aligned to the client’s portfolio of licensed products. The manager is responsible for the RA activities of assigned products in Emerging Markets working in collaboration with the client’s global functions and affiliate companies and partners across EM.

Providing EM strategic and functional input to the global team, the Manager of EM Regulatory Affairs will plan, manage and execute regulatory activities on licensed products.

Other responsibilities will include:

  • Responsible for EMRA strategic input for assigned products throughout its lifecycle
  • Submission of variations, renewals, line extensions, responses to requests for further information and marketing authorisation applications in additional EM countries
  • Interfaces cross-functionally within RA, as well as with Commercial, Clinical Development, Global Marketing, etc. to identify what EMRA requirements will impact the global strategy and how to best move forward to meet project plans
  • Communicate with Regulatory Authorities to facilitate productive dialogue on assigned products
  • Liaise with external companies with respect out-licensing supporting activities as required
  • Handling of regulatory documents in the electronic document management system
  • Regulatory assessment of change requests
  • Provide EM regulatory intelligence to product teams

You are:

A team worker with the ability to influence in order to achieve objectives. You will have excellent organisational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • A degree in pharmacy/life sciences or similar
  • Direct experience in EM Regulatory Affairs
  • Proven experience of making new marketing authorisation applications and post-marketing activities in EM
  • Some experience of interactions with Regulatory Authorities
  • Proven ability to provide strategic regulatory guidance for registration and post-marketing activities
  • Demonstrated leadership and have strong problem-solving abilities, negotiation and communication skills
  • Demonstrated the ability to work independently and function well in a team-orientated environment

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

Apply for this job: MANAGER, EMERGING MARKETS REGULATORY AFFAIRS  -  Spain, Italy, Germany, United Kingdom

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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