Allergan Sr Regulatory Affairs Analyst in Buckinghamshire, United States

Sr Regulatory Affairs Analyst

Buckinghamshire, England, United Kingdom at

Aug 03, 2018Post Date

182260Requisition #

The Senior Analyst, RA supports the implementation of registration strategy for assigned products in the Europe Region. They provide support in assigned product maintenance and lifecycle management submissions, in line with legal/regulatory requirements and regional business needs as well as support clinical trials strategy as required. They will have some experience with regulatory procedures and contribute to the effective functioning of the Europe Region Regulatory Affairs team.

The Senior Analyst will also contribute, as required, in the development of regional processes to maximise operational efficiency of regulatory activities within the region. There is an expectation that they will develop and maintain knowledge of regulatory procedures and environment within the region.

Key Responsibilities

  • With supervision,ensure that teams and functional groups are provided with clear, constructiveregulatory advice and intelligence to assist planning and issue resolutionduring product development and registration.

  • With supervision,plan and implement regulatory activities in support of lifecycle management andmaintenance in the region. Identifycompliance risks proactively.

  • With supervision,support co-ordination of the review of CMC, QRD, PSUR and labelling submissionsand approval of product-related packaging as required to ensure regulatorycompliance.

  • With supervision,provide appropriate Europe Region regulatory input to project teams and GlobalRegulatory Slides via the Global Liaison and Global Regulatory Teams.

  • Ensures planneddrug development activities comply with guidelines and in cases where they donot provide a critical analysis of the risks and issues.

  • Makerecommendations to Global Regulatory and drug development teams in order toshape the global strategy in line with regional/commercial objectives

  • Support the drugdevelopment strategy; defining options for Scientific Advice/PIP/IMPD, creatingbriefing packages and co-ordinating and supporting EU agency meetings.

  • Define EuropeRegion filing strategy (including CP, MRP, DCP); identifying risks and issues.

  • Responsible for implementingand ensuring effective planning, tracking, archiving of activities, especiallysubmissions, internal memos and key correspondence. Ensure effective planningand tracking of activities via RIM system.

  • With supervision,support the communication of regulatory strategy in support of new productregistration, in line with commercial objectives.

  • Build strong andeffective relationships with “in country” teams thereby ensuring local RAactivities are in line with regional business priorities.

  • Follows core GRApolicies and procedures.

  • Supportimplementation of new processes and input into changes in processes, asrequired

  • Responsible forthe Notification of Regulatory activities and related database entry/dataaccuracy for allocated projects.

  • With supervision,provides forecasts and actuals and manage in line with regional requirements,communicating these to Europe Region TA Head, GRL and R&D finance forassigned projects

  • Follow allapproved Allergan regional procedures and guidance

Education and Experience

  • Graduate in LifeSciences in a relevant area.

  • Some knowledge ofboth pharmaceutical regulations and guidelines and national regulations withinthe assigned region.

  • Prior relevantexperience in pharmaceutical industry or Regulatory Affairs

Essential Skills and Abilities

  • Ability to planand organise workload including managing multiple projects.

  • Ability to workeffectively and collaboratively across the Allergan organisation.

  • Goodinterpersonal and negotiation skills.

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

  • Positive, can doattitude

  • Willingness totravel as necessary.

  • Computer literate


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.