Allergan Senior Manager, Regulatory Affairs in Buckinghamshire, United States
Senior Manager, Regulatory Affairs
Buckinghamshire, England, United Kingdom at https://agn.referrals.selectminds.com/jobs/5866/other-jobs-matching/location-only
Jul 03, 2018Post Date
The Senior Manager, Regulatory is responsible for the implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. They are also responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. The incumbent is also required to support clinical trials strategy as required.
The ideal candidate will have strong experience with EU regulatory procedures (CP, DCP, MRP) and a successful track record in contributing to the effective functioning of a Europe Region Regulatory Affairs team. They will contribute, as required, in the development of global and regional processes to maximise operational efficiency of regulatory activities within the region. There is an expectation that the successful candidate will develop and maintain excellent knowledge of regulatory procedures and environment within the region.
The role is based at our International offices in Marlow.
KEY DUTIES AND RESPONSIBILITIES
Responsible for appropriate Europe Region regulatory input to projectteams and Global Regulatory Slides via the Global Liaison and Global RegulatoryTeams.
Responsible for ensuring planned drug development activities complywith Europe Region guidelines and in cases where they do not provide a criticalanalysis of the risks and issues.
Make recommendations to Global Regulatory and drug development teams inorder to shape the global strategy in line with regional/commercial objectives
Support the drug development strategy; defining options for ScientificAdvice/PIP/IMPD, creating briefing packages and co-ordinating and leading agencymeetings.
Define Europe region filing strategy (including CP, MRP, DCP);identifying risks and issues.
Responsible for ensuring effective implementation of filing plan,publishing and archiving of documents.
Responsible for ensuring effective planning, tracking, archiving ofactivities, especially submissions, internal memos and key correspondence. Ensureseffective planning and tracking of activities via RIM system
Responsible for the communication of regulatory strategy in support ofnew product registration, in line with commercial objectives.
Responsible for ensuring that teams and functional groups are providedwith clear, constructive regulatory advice and intelligence to assist planningand issue resolution during product development and registration.
Drives and leads regulatory activities in support of lifecycle managementand maintenance in the region. Identifies compliance risks proactively.
Supports co-ordination of the review of CMC, QRD, PSUR and labellingsubmissions and approval of product-related packaging as required to ensureregulatory compliance.
May be required to mentor junior staff as required
Establish strong and effective relationships with “in country” andglobal regulatory teams thereby ensuring RA activities are in line withregional business priorities.
Ensures that new processes are developed and implemented in order toleverage the global infrastructure and maximise efficiency, ensures that newprocesses are aligned with global policies, but also meet regional regulations andneeds
Responsible for the Notification of Regulatory activities and relateddatabase entry/data accuracy for allocated projects.
Responsible for ensuring forecasts are developed and actuals managed inline with regional requirements and communicating these to GRL and R&Dfinance for assigned projects
Education and Experience
Graduate in Life Sciences in a relevant area.
Sound knowledge of both pharmaceutical regulations and guidelines andnational regulations within the assigned region.
Prior relevant experience in pharmaceutical Regulatory Affairsincluding development, registration and lifecycle management of pharmaceuticalproducts
Essential Skills andAbilities
Demonstrated planning and organisation skills.
Ability to prioritise and manage multiple projects.
Ability to work effectively and collaboratively across the Allerganorganisation.
Good interpersonal and negotiation skills and the ability to influenceothers without formal authority.
Excellent communication skills, both written and verbal (in English).
Positive, can do attitude
Willingness to travel as necessary.
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.