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MSD Ireland

Regulatory Lead Job

MSD Ireland

  • Carlow
  • Negotiable
  • Permanent full-time
  • Updated 22/02/2013
  • Merck
this job is expired
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Regulatory Lead Job


Regulatory Lead-REG000997


The position of the Regulatory Lead is designed to provide day to day Regulatory support for site, new product and existing product activities.

The Regulatory Lead's primary tasks and responsibilities of the position are as follows:

- Management of Regulatory Support Area

- Management of Irish Medicines Board Manufacturing Licences

- Management of Product Licenses/Marketing Authorisations/Clinical Trial

Authorisations as appropriate

- Management and/or Creation of Product Specification Files

- Manage and facilitate all registration related activities

- Input into Site Master File

- Create/Implement Regulatory Process SOPs

- Input into Change Control system (Site and Global)

- FAR and BPDRs

- Maintain BOH Communication Log

- Maintain Product and Site Licence Retention

- Dealing with general Regulatory Requirements

- Work in co-ordination with Regulatory CMC Group (USA)

- Assistance with all Regulatory Inspections

- Part of the New Product Introduction Teams

- Co-ordination of the work to deliver a quality and efficient support service

- Delivery of area performance to meet or exceed performance and quality goals

- To exercise financial acumen

- Ensure compliance with cGMP and other business compliance regulations

- Participate in risk assessments, inspections, audits, incident investigations, etc.

and implement and follow-up related CAPA's.

- Responsible for driving a culture of Continuous Improvement by

deploying Merck Six Sigma tools within the area


The successful applicant will possess the following knowledge, skills, qualifications and experience.

Job Experience:

- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering etc.).
- At least 5 years experience in a Regulatory based role within the Pharmaceutical industry or similar operating environment which includes significant leadership role with experience in a front-line supervisory role in operations environment.
- Knowledge of and experience in applying Six Sigma and Lean methodologies.
- Demonstrated leadership and change management skills with a continuous improvement focus.

- Qualifications:
- Degree or 3rd level qualification (Science/Technical).
- Desirable MSc qualification. Minimum requirement is to advance to this level within 3 years if existing job experience allows.
- Desirable - Project Management qualification such as Project Management Professional
- Desirable evidence of Continuous Professional Development
- Preference Lean Six Sigma Green Belt

- Skill Set:
- Leadership Skills
- Technical Knowledge
- Ability to respond to changing priorities
- Problem solving skills
- Communication skills

Key Behaviours:

- Shared Accountability and Transparency
- Cross-functional Teamwork and Collaboration
- Benchmark and Continuously Improve
- Listen and Learn
- Coach and develop others
- Business Integrity

Job: Regulatory Affairs Generic

Job Title: Sr. Spclst, Quality Control

Primary Location: EMEA-IE-Leinster-Carlow

Employee Status: Regular

Number of Openings: 1

To apply for this position please click here

Ref: REG000997_1360972927
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MSD Ireland

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