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Manager Regulatory Affairs

Major Duties and Responsibilities
• Ensures company’s lifecycle management regulatory affairs activities are conducted according to
relevant regulations, laws, and standards.
• Oversees the company’s regulatory application process to obtain all necessary updates to permits,
licences, certificates, authorizations, etc.
• Establishes and maintains good relationship with regulatory authorities.
• Interfaces with functional managers and understands their business needs (e.g. formalising necessary
change to dossiers) and tech transfers
• Provides advisory to company’s management on emerging regulations that may affect the existing dossiers.
• Manages a team of regulatory affairs professionals
• Oversees all regulatory actions for CAPAs, AERs and change control.
• Undertakes such other reasonable duties as may be required from time to time to support the
department and business activities.
• Acknowledge responsibility to ensure an effective Quality Management System in order to achieve
Quality Objectives.
Competencies
• A good understanding of the engineering principles underpinning key manufacturing systems.
• Current awareness of legal framework and forthcoming legislation that may affect the business
• Good understanding of the workings of global competent authorities.
• Good understanding of variations in UK and EU. Knowledge globally would be beneficial.
• Detailed CMC knowledge; eCTD beneficial
• Ability to motivate team members, provide coaching and support development.
• Shows initiative and drive
• Demonstrates excellent planning abilities with flexibility and agility
• MS-Office knowledge essential
• Excellent written and verbal communication skills essential
• Minimum 2 years experience in supervisory or management roles
Knowledge and Experience
•Typical Years of Experience-6-8 years experience
•Minimum Expected Education-Level 6 – Bachelor’s Degree
•Additional Information-Typically a minimum of 6 years in the field and 2
years supervisory experience. University Degree or
equivalent required
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