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Regulatory Affairs Senior Manager/Associate Director

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
1 Dec 2021
Closing date
16 Dec 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

My client, a global pharmaceutical company now have a new vacancy for a Regulatory Affairs Senior Manager/Associate Director.   Exciting opportunity to join a fast-paced growing company.   In return you get autonomy and a flexible/hybrid work environment.

The purpose of this new role is to take a hands-on lead and responsibility for the operational life-cycle management projects and support strategic decision making for some marketed products. Provide support on expansion on current registered portfolio and R&D pipeline assets as needs develop.  Promote high quality regulatory best practices, strategy definition, process efficiencies, effective communication, financial expediency, planning, reporting and delivery of GRA and Corporate projects. 

 Positive approach and attitude in a busy global multi-stakeholder company to help deliver high quality and timely registrations, local and global team build and support corporate growth and patient treatment options. Line Management of more junior team member (internal and external).

 

Key Responsibilities:

  • Acts as responsible Senior Regulatory Team member and representative for assigned regulatory projects 
  • Provide support to Regulatory leadership on Operational activities and Strategy
  • Manage and lead internal and external personnel on life-cycle maintenance activities 
  • Effectively plan, manage, and deliver high-quality regulatory project support
  • Preparation and responsibility for regulatory filings; including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, publishing, CMC authoring and \ or updates as required in line with corporate needs and timelines. 
  • Effective high-quality communication with Regulatory Authorities
  • Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional Heads). 
  • Project finance: planning, maintaining tracking/oversight of external vendor fees, Regulatory Agency fees

 

 

Qualifications & Experience: 

 

  • Scientific Primary and /or advances Degree(s)
  • >7 years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g., variations, renewals, new Marketing Authorisation Applications (MAAs) submissions) 
  • Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts 
  • Experience of EU DCP and MRP MAAs 
  • Experience of emerging markets / international RoW markets and regulatory filings
  • Experience of Women’s and/or Men’s healthcare – an advantage
  • Experience of US Regulatory Affairs – advantageous 
  • Experience of Medical Devices – advantageous

For full job spec and confidential discussion contact Tina at +353 1 2784701/0876811990 or email your CV to tdunne@thornshaw.com Thornshaw Scientific is a division of the CPL Group www.thornshaw.com     

Company

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Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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