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Job Details

Regulatory Affairs CMC Manager

Company: Thornshaw Recruitment
Location:
Reference: TD9968
Closing Date: 14 Jan 19
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

On behalf of my client we are sourcing a candidate for the role of Regulatory Affairs CMC Manager.   This is a permanent role.

Requirements:

On behalf of my client we are sourcing a candidate for the role of Regulatory Affairs CMC Manager.   This is a permanent role.

PURPOSE / KEY RESPONSIBILITIES: 
•    Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies 
•    Review the preparation of CMC components for filings and assess fitness of purpose for submission in the relevant countries 
•    Gathering, consolidating and analysing regulatory intelligence for the EU & ROW territories and support its application to product-specific activities 
•    Ownership/ regulatory responsibility for a portfolio of products for nominated client; via a range of regulatory activities including submission of new marketing authorization applications, variation applications and renewals.  
•    Work with the Managing Director and Project Manager to ensure that client deadlines are met and that appropriate resources are allocated to the various projects 
•    Maintain communication with client and Regulatory teams to ensure that projects are delivered in keeping with our responsibilities to the client. 
•    Builds and maintains strong relationships with EU competent authorities to ensure ease of access & influence. 
•    Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to the company's products. 
•    Supports EU regulatory initiatives and issues as appropriate.  
 
 Knowledge and Skills 
•    BSc (MSc or higher preferred) life sciences, or related field 
•    7-10 years related experience within Pharmaceutical Regulatory Affairs 
•    Experience with global legislation and regulations relating to medicinal product registration 
•    Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, line extensions and renewals. 
•    Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage 
•    Ability to project manage across a diverse and complex portfolio of products and priorities.  

For further details on this vacancy contact Tina at +353 1 2784671 or email your CV to tdunne@thornshaw.com.   Log on to www.thornshaw.com for a full list of available vacancies.   Thornshaw is a division of the CPL Group

Apply for this job: Regulatory Affairs CMC Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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