Job Description
A fantastic opportunity has arisen for Regulatory Affairs Specialist 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:
(may not be limited to):
- Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorisation applications to the local authorities and – as applicable – to the EMA.
- Ensure maintenance of assigned, authorised products through timely submission of variations, renewal applications, and supplemental marketing authorisations.
- For assigned products ensures high quality labelling translation and artwork management.
- 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 RAE Liaison, and other internal stakeholders.
- Stay updated on relevant EU and local regulations and guidelines.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional, regional and global level, our Manufacturing Division, EUQPPV and GSC&PV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
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 the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
- Ability to communicate well verbally and in writing, good organizational and planning skills, a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work
- A sound appreciation of the interactions and relationships with other groups internally, a client-oriented approach and work according to the company leadership vision
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, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
10/12/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R315092