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Regulatory Affairs Specialist

Job Seekers Ireland Science Pharmaceutical

Job Summary

  • Cork
  • Permanent
  • BBBH771681
  • Dec 09, 2020
  • Competitive
Job Description

Excellent Regulatory Affairs Specialist role available with a leading pharmaceutical manufacturer based in Cork. Please see below for more details on this excellent role.

Excellent opportunity available to join a leading pharmaceutical based in Cork. This role has come up as part of an exciting new development. It's a great time to join this pharmaceutical and grow and develop within the organisation. For more information, please apply below or email jfitzpatrick@morganmckinley.com

Purpose Of Job

Reporting to the Regulatory Affairs Senior Manager, the post holder will have responsibility for monitoring private label regulatory compliance in the US. The key function of this role is to minimize the risk to private label business by ensuring a high level of regulatory compliance, supporting regulatory submissions and ensuring product safety and labelling compliance. The post holder will assist in the monitoring of multiple global suppliers to ensure regulatory compliance, generate metrics and prepare reports for the regulatory department.

Key Responsibilities

  • Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements (FDA, DSCSA, CBP, DEA), including but not limited to
  • Understand and review compliance requirements across a portfolio of Drugs, Medical Devices, Combination products, Cosmetics and Dietary Supplements
  • Issue NDCs in accordance with CFR guidelines
  • Issue UPC codes for new item set up
  • Manage drug listings lifecycle (SPL review, re-certification and de-listings)
  • Compile technical package for Centre for Medicaid Services registration (CMS) and First Data Bank registrations
  • Support additional State or Federal registration processes as required
  • Support Global Unique Device Identification GUDID registrations
  • Contribute and respond to Competent Authorities' queries and deficiencies in a timely manner
  • Support regulatory authority compliance audits

Support labelling activities including but not limited to:

  • Review, approve and monitor artwork changes for contracted, commercialized and pipeline private labels for the US market to ensure compliance in accordance with ANDA filings, OTC monographs, FDA and private label brand guidelines
  • Act as a key contributor on labeling aspects by applying best practices and performing regulatory due diligence and impact assessments on labeling requirements (including but not limited to DSCSA requirements, CBP and COO requirements)
  • Interpret, analyze, compare and make decisions regarding labelling content, in collaboration with labelling stakeholders
  • Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business
  • Liaise effectively with internal departments and external suppliers to support the timely introduction of new products to market
  • Ensure compliant operation and maintenance of internal processes and systems for accuracy of content
  • Ensure the effective implementation of a quality management system in the Regulatory function
  • Work as a team member in developing the regulatory oversight of suppliers
  • Preparation of monthly metrics and reports to monitor and cross-compare the quality systems
  • Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
  • Be flexible within the Regulatory function to meet the needs of the growing business using technical expertise, skills, knowledge and experience
  • Support cross-training opportunities and skills
  • Provide day-to-day department support activities as necessary to aide completion of project deliverables
  • Perform general duties as required by the Director of Regulatory Affairs

ADDITIONAL RESPONSIBILITIES AND DUTIES

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management.

REQUIREMENTS

Education/Training:

Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline

Experience:

5+ years regulated pharmaceutical experience; 3+ years regulatory affairs experience

Knowledge and Skills:

  • Thorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturing with an emphasis on labeling content
  • An understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately
  • Excellent interpersonal skills, self-motivation and sense of urgency to complete assignments on time
  • Excellent communication skills with ability to communicate at all levels within the organization
  • Ability to work independently and make decisions based on judgement and integrity
  • Proven analytical and problem-solving skills and the ability to transfer findings into report and presentation formats
  • Ability to work effectively with others to accomplish goals in a challenging environment
  • Excellent organisational and time management skills
  • Understanding of customs and beliefs of other groups or cultures
  • Familiarity with concepts of Regulatory Approval process for generic pharmaceutical products an advantage

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

julieann-fitzpatrick
Julieann Fitzpatrick
  • Senior Consultant
  • 353 (0) 21 2300300
  • jfitzpatrick@morganmckinley.com