Regulatory Affairs Contract - RECORDS

Description

Summary

One of the largest pharmaceutical companies based in the South East are seeking a number of Regulatory Affairs Consultants urgently, on an interim basis. They are willing to pay up to £40 an hour for the ideal candidate.

Role

• To manage projects and product-related registration strategies in the assigned countries.
• To ensure that regulatory documentation meet relevant regulatory requirements.
• To apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorisation dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
• To ensure business continuity between headquarter Product Strategists and Regulatory staff.
• Apply regulatory expertise for assigned countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
• Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.

Requirements

• Manage regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
• Ensure product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
• Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.

Skills and experience

• Scientific degree
• Appropriate Regulatory Affairs experience - minimum 2-4 years
• Proven ability to manage complex regulatory or drug development issues.
• Proven ability to consistently deliver to time, cost and quality standards.

Note: If you know anyone that you feel suits this role, please forward this on; we offer £200 worth of vouchers if your referral is placed successfully.