Allergan Manager, Regulatory Affairs in Buckinghamshire, United States

Manager, Regulatory Affairs

Buckinghamshire, England, United Kingdom at https://agn.referrals.selectminds.com/jobs/6572/other-jobs-matching/location-only

Sep 10, 2018Post Date

183057Requisition #

Based at our International offices in Marlow, the role of the Regulatory Manager is to support the implementation of registration strategy for assigned products to ensure the regulatory approval of commercially successful pharma products in the European region (EU) and European economic Area (EEA). They will be responsible for assigned product maintenance and lifecycle management submissions, in line with legal/regulatory requirements and regional business needs. The manager also supports clinical trials strategy as required.

The ideal candidate will have experience with EU regulatory procedures (CP/DCP/MRP) and is expected to contribute to the effective functioning of the EMEA Regulatory Affairs team. This will also mean involvement, as required, in the development of regional processes to maximise operational efficiency of regulatory activities within the region.

The successful candidate will be expected to develop and maintain knowledge of regulatory procedures and environment within the region.

Education and Experience

  • Graduatein Life Sciences in a relevant area.

  • Soundknowledge of both European pharmaceutical regulations and guidelines andnational regulations within the assigned region.

  • Priorrelevant experience in pharmaceutical Regulatory Affairs

Essential Skills and Abilities

  • Demonstratedplanning and organisation skills.

  • Abilityto prioritise and manage multiple projects.

  • Abilityto work effectively and collaboratively across the Allergan organisation.

  • Goodinterpersonal and negotiation skills and the ability to influence otherswithout formal authority.

  • Excellentcommunication skills, both written and verbal (in English).

  • Positive,can do attitude

  • Willingnessto travel

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.