I am delighted to be working with an exciting, progressive Pharmaceutical company based in Dublin who are seeking a Regulatory Affairs Manager to join their growing team.
This is a permanent position with the flexibility of a work from home option.
This company is continuously expanding and bringing innovative patient friendly products to the market internationally. The successful person will be responsible for leading all regulatory activities within the company. It is a standalone role reporting to the technical director.
3 years experience in Regulatory Affairs or Quality coming from a Pharmaceutical Industry.
Direct CMC and GMP experience are essential.
Experience looking after regulatory requirements in line with ICH guidelines.
Working knowledge of Global Markets including US and EU.
Excellent Project management skills.
Flexible, team player who can influence and lead.
Executing all regulatory activities for projects in line with ICH guidelines.
Prepare, update and review submissions in conjunction with other departments and external partners.
Work on the global strategy required for the EU, US and ROW.
Working on new and existing dossiers ensuring relevant and new submissions are updated in line with regulatory authorities.
Dealing with external customers on a daily basis on all regulatory activities.
Actively participate in internal meetings with regulatory authorities.
If this role is of interest to you please click 'Apply Now' or for more information contact Aoife on email@example.com or 021 2300 200.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.