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Head of Regulatory Affairs

2 months ago

Camden Area, United Kingdom Walker Cole International Full time
Walker Cole International is working with an exciting global pharmaceutical company that is recruiting for a Head of Regulatory Affairs to join a growing Pharmaceutical business on a permanent basis.

The organisation is an innovative business with a broad portfolio of products across a range of therapeutics and dosage forms. The company offers a competitive salary and flexible working policy, with time in the office and working from home. As the Head of Regulatory Affairs you will be responsible for all lifecycle maintenance activities across the product portfolio for the business and lead a small team.

The main responsibilities will include:

Develop Regulatory strategies for innovative and rapid access to new markets inc. Emerging Markets/Rest of World (ROW).nManage routine Manufacturing Authorisation (MA) maintenance activities for National and MRP procedures including compilation and submission of variations and renewals.nEnsure submissions of Marketing Authorisation Applications (MAAs) in European and Global territories can be successful.

The successful candidate will:

Have a Life Science degree or equivalentnSignificant experience in the pharmaceutical industry leading a Regulatory Affairs FunctionnStrong knowledge of Emerging Markets/Rest of World (ROW) RegulationsnProven experience in Regulatory Affairs within either an R&D or Established product environment

Regulatory Affairs | RA | Senior Manager | Manager | EU | European Union | MHRA | EMA | European Medicines Agency | Post-approval | New Product Introduction | Product Launch | MAA | Marketing Authorisation Application | Lifecycle Maintenance | Rest of World | Emerging Markets |

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