Senior Specialist Regulatory Affairs

Job Description

A fantastic opportunity has arisen for a Senior Specialist Regulatory Affairs at our Red Oak North office.  Red Oak North in Dublin is our commercial Head Office for our Animal Health and Human Health businesses in addition to several global and national support services including Clinical Research, Medical Affairs, Regulatory Affairs, Sales, Policy & Communications and Marketing. 

Bring energy, knowledge, innovation to carry out the following:

• For assigned products, ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorisation applications to the local authorities and – as applicable – to the EMA.
• Ensures maintenance of assigned, authorised products through timely submission of variations, renewal applications, and supplemental marketing authorisations.
• For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
• Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with Regulatory Affairs Europe Liaison, and other internal stakeholders.
• For assigned products and tasks, stays updated on late  pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• For assigned products and tasks, works alongside the Business Director, locally, regionally, and globally, to support business initiatives in sub region.
• Maintains a positive relationship with internal and external regulatory contacts.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Must hold a degree in pharmacy or other life science or equivalent.
• An approx. minimum of 2 years’ experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
• Appreciation of the interactions and relationships of the dept with other groups internally is expected.
• Be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.
• Ability to convey messages well verbally and in writing is essential, as are good organizational and planning skills.
• Attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introdu