Regulatory Affairs Manager – Donegal

  • Reference: SJ46980
  • Job Type: Permanent
  • Location: Donegal
  • Category: Science, Pharmaceutical & Food

Our client, a leading company in Donegal, is seeking a Regulatory Affairs Manager.

Purpose

The Regulatory Affairs Manager applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or postmarket change management activities into global markets. Coordinate preparation of well organized, complete, and scientifically sound regulatory submissions. Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications. Exercise judgement within generally defined practices and departmental standard operating procedures. Accountable for budgets, schedules, and ensuring compliance to divisional and corporate policies as required. Develop and maintain strong and effective relations with internal/external personnel.

Responsibilites:

Works with Regulatory leadership to develop and implement regulatory strategies for product introductions and modifications per agreed schedule

Maintains strong communication and working relationships with all departments across division sites, Third Party Manufacturers, suppliers, and external personnel

Ensures that appropriate documentation is maintained to record regulatory decisions and verification/validation evidence in support of change control activities related to product design or manufacture.

Maintain a high level of technical understanding with all new products.

Provides strategic regulatory input (including all feasible alternatives and associated risks) and drives cross-functional alignment with issues that could have regulatory ramifications

Maintains the effectiveness of the Quality System at the site in accordance with divisional and corporate requirements and applicable regulations.

Manages the preparation of registration documents as required for international markets

Provides input and comment on regulations and standards which may affect division products


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Colin Byrne

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