Regulatory Affairs Manager (Epping) at Aspen Pharma Group

Description

• Purpose: To ensure that resources are effectively utilised within the RA Department to meet all regulatory requirements of local and international regulatory authorities and that FCC operates in compliance with these regulatory commitments contained in submissions such as DMFs/AIFs/CTDs/CEPs.

BASIC JOB TASKS INCLUSIVE BUT ARE NOT LIMITED TO THE FOLLOWING:

• Manage the compilation, updating, and submission of regulatory dossiers to local and international regulatory authorities in support of customer ANDAs and NDAs.
• Manage the close-out of requests for additional information that are received from regulatory authorities and customers.
• Manage the compilation of PPQ and Comparability protocols and reports.
• Manage continuous process verification activities through the annual product quality review program..
• Manage the compilation/update of various documents in the overall Quality System.
• Manage the Change Control System and ensure that users are conforming to regulatory requirements.
• Ensure that the various RA databases (CIP, CPP, CQA, MBPR, CCR, PC, etc.) are maintained.
• Manage the execution of FCC's regulatory commitments.
• Manage employee performance, training & development, maintain discipline, recruit staff & daily leadership. 
• Maintain department expenses in line with budget and mitigate increasing costs via effective CIP programs.

PERSONAL ATTRIBUTES (Brief Summary)

• Proven leadership, interpersonal and organizational skills.
• Exceptional attention to detail and accuracy
• Proven editorial and document reviewing skills, including the ability to critically evaluate data.
• Systems-orientated and meticulous attention to detail
• Proven track record of integrity and honesty.
• Assertive and confident at all levels

Requirements

JOB REQUIREMENTS:

• Degree in Chemistry or equivalent Qualification.
• Good knowledge of chemistry (Analytical and Organic).
• Proven systematic thinking and operating abilities.
• Proven experience in pharmaceutical, GMP, or chemical manufacturing environment.
• Minimum of 5 years of proven experience in a pharmaceutical regulatory environment (API or FDF).
• Minimum of 3 years’ experience at Line Management level.
• Computer literacy in various MS Office, e.g. Word, Excel, Outlook, Access, Sharepoint, etc.