CAREERS

Job Title: Regulatory Affairs Advisor

Reports To: Dr. Gemma Robinson,

Business Division: Regulatory Affairs, based in Dublin, Ireland.
Essential skills / Qualifications Required:
(Education/Experience/Competencies)

• B.Sc. Minimum or pharmacy primary degree.
• Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry.
• Experience in the Medical Device Sector for EU markets - advantage.
• Experience with NeeS/eCTD submissions
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
• Proficiency in Manufacturing Site Changes and CMC profiles.
• Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets.
• Experience in the management of DCP’s, Centralised or other European procedures
• Excellent written and oral communication skills.
• Ability to project manage across a diverse and complex portfolio of products and priorities.
• Ability to get on with people, to influence people both internally and externally and to achieve objectives.
• Above average attention to detail and solid interpersonal, communication and organisational skills required.
• Be an authority on the Irish and European Regulatory Framework.
• Excellent attention to detail with Client Care an integral part of your work ethic.
• Confidentiality and discretion.
• Motivated self-starter.
• Ability and desire to progress.
• Strong work ethic.
  
  
  
  PURPOSE / KEY RESPONSIBILITIES:
  
  

1. Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
2. Medical writing, review of SPC, labeling and management of local prescribing information during product lifecycle.
3. Proposes and implements effective strategies to minimise the timing of and optimise the commercial viability of product licences.
4. Responsibility for the preparation of Package Leaflet User-Test or Bridging Reports.
5. Builds and maintains strong relationships with EU Competent Authority to ensure ease of access and influence.
6. Provision of guidance/technical support in the preparation of EU CTD dossiers applications including eCTD & NeeS submissions
7. Responsibility, ownership and execution of Internal Audits, creating reports and feedback on findings.
8. Support other team members with the implementation of the QMS and objectives to achieve ISO 9001

Job Title: Regulatory Affairs Advisor, Pharmacovigilance

Reports To: Dr. Gemma Robinson,

Business Division: Pharmacovigilance Dept.
Essential skills / Qualifications Required:
(Education/Experience/Competencies)

• B.Sc. Minimum or Pharmacy primary degree.
• Greater than 3 years experience in Regulatory Affairs in the Pharmaceutical Industry.
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
• Rounded knowledge of the national and EU regulatory framework.
  
• Excellent written and oral communication skills.
• Ability to project manage across a diverse and complex portfolio of products and priorities.
• Ability to get on with people, to influence people both internally and externally and to achieve objectives.
  
• Above average attention to detail and solid interpersonal, communication and organisational skills required.
• Ability to work independently with minimal supervision.
• Motivated self-starter.
• Ability and desire to progress.
  
  
  
  PURPOSE / KEY RESPONSIBILITIES:

1. Duties of a Qualified Person and/or Deputy
   • Writing of Periodic Safety Update Reports and searching for ADRs
   • Assessing adverse reactions for potential signals
   • Producing summary safety tables for Client review
   • Preparation and training for Regulatory Inspections
   • MedDRA coding
   • Understanding and helping with determining ADR reportability
   • SOP review and writing.
   
   
2. Compilation of Risk Management Plans.
3. Protects the assets of both Acorn and the client company within their responsibility by effectively and proactively managing emerging issues which impact the competitiveness of the licenses.
4. Builds and maintains strong relationships with all personnel within the Irish Medicines Board or appropriate competent authority to ensure ease of access and influence.
5. Be an authority on the regulatory framework in Ireland and Europe.
6. Supports EU regulatory initiatives and issues as appropriate.
7. Works collaboratively with other department colleagues to share best practice and information and ensure a consistent approach with both Competent Authority & within company.
8. Responsibility for the medical review and approval of medicinal product advertising and promotional materials for the Irish market as per client requirements.
9. Providing advice and support on Medical enquiries and other medical aspects relevant to the business.

Job Title: Regulatory Affairs Advisor, Medical Devices

Reports To: Dr. Gemma Robinson,

Business Division: Regulatory Affairs
Essential skills / Qualifications Required:
(Education/Experience/Competencies)

• B.Sc. Minimum or Pharmacy primary degree.
• Minimum of 3/4 years experience within Regulatory Affairs or Compliance in a Medical Device Environment
• Be an authority on EU Medical Device Directives and be able to provide support as necessary
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and
  advice.
• Excellent written and oral communication skills.
• Ability to project manage across a diverse and complex portfolio of products and priorities.
• Ability to get on with people, to influence people both internally and externally and to achieve objectives.
• Attention to detail and solid interpersonal, communication and organisational skills required.
• Ability to work on own initiative with minimal supervision, self starter and as part of a team.
  
  
  
  PURPOSE / KEY RESPONSIBILITIES:

1. Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for
   close liaison with the Management/ other key personnel of the relevant business unit in the definition of
   product strategies in line with timeframes for approval.
2. Builds and maintains strong relationships with EU Health Authorities as appropriate to ensure ease of access
   and influence.
3. Ensures customer queries are handled in appropriate manner and comprehensive manner, and records are
   kept of all communication both external and internal.
4. Be an authority on the regulatory framework in Ireland and Europe in particular in the Medical Device area
5. Supports EU regulatory initiatives and issues as appropriate
6. Works collaboratively with other department colleagues to share best practice and information
7. Management / review of Non-conformances
8. Preparation of Annual Product Reviews and generate documents as necessary for management review
9. To ensure that all activities relating to associated Internal Audits are carried out and to co-ordinate the preparation activities for External audits
   

Job Title: Regulatory Affairs Advisor
Business Division: Regulatory Affairs, based inClonmel Co. Tipperary
Reports To: Dr. Gemma Robinson

Qualifications/Minimum Required:
(Education/Experience/Competencies)

• B.Sc. Minimum or pharmacy primary degree.
• Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical
  Industry.
• Experience in the Medical Device Sector for EU markets - advantage.
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and
  advice.
• Rounded knowledge of the national and EU regulatory framework.
• Excellent written and oral communication skills.
• Ability to project manage across a diverse and complex portfolio of products and priorities.
• Ability to get on with people, to influence people both internally and externally and to achieve objectives.
• Above average attention to detail and solid interpersonal, communication and organisational skills required.
• Ability to work independently with minimal supervision.
• Motivated self-starter.
• Ability and desire to progress.
  
  
  
  
  
  PURPOSE / KEY RESPONSIBILITIES:

1. Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for
   close liaison with the Management/ other key personnel of the relevant business unit in the definition of
   product strategies in line with timeframes for approval.
2. Proposes and implements effective strategies to minimise the timing of and optimise the commercial viability
   of product licenses.
3. Responsibility for the preparation of Package Leaflet User-Test or Bridging Reports.
4. Builds and maintains strong relationships with EU Competent Authority to ensure ease of access and
   influence.
5. Provision of guidance/technical support in the preparation of EU CTD dossiers applications including eCTD &
   NeeS submissions
6. Support other team members with the implementation of the QMS and objectives to achieve ISO 9001