Latest Regulatory Affairs Vacancies

This is a very positive time to be a specialist with experience in the regulatory affairs sector.  We are working with a number of our consultancy clients to help them with new roles that they are creating in Ireland.  Furthermore, it is a very busy time for us at Acorn Regulatory.  We are also recruiting for our facility in Ireland right now. Here are some of the latest regulatory affairs vacancies that we are seeking to fill.

Latest Regulatory Affairs Vacancies

Firstly, we are recruiting for specialists to join our own team in Quality and RP roles.

Quality Specialist (Part-Time)

Job Description:

Key Responsibilities:
Manage and maintain the company’s quality management system (QMS).
Develop, manage, maintain and analyse Key Performance Indicators (KPI’s) and escalates to management as appropriate.
Ensure compliance to appropriate ISO standards (ISO 9001:2015)
Ensuring compliance to the Internal Audit program and conduct internal audits.
Analysis of QMS performance and communicate results via Quality Review Meetings and Management Review Meetings.
Review and approve documents internally and for external clients.
Participates or serves as lead Quality Representative on process improvement initiatives.
Collaborates with cross functional partners to identify and implement improvements.
Education and additional requirements:
• B.Sc. in Science related discipline as minimum.
• More than 3 years’ experience in the area of Quality Assurance.
• Experience and knowledge of ISO 9001 standard, GMP and GDP Guidelines
• Relevant auditing qualification, i.e. Lead Auditor
• Knowledge of US and EU Regulations (ICH, EU GMPs, GDPs, ISO, etc.)
• Knowledge of electronic data systems.
• Demonstrated proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, and Access); Project and Visio.

 

Responsible Person (RP) (Part-Time)

Job Description:

Key responsibilities:
Ensuring that a Quality Management System is implemented and maintained;
Management of authorised activities and the accuracy and quality of records;
Ensure that initial and continuous training programmes are implemented and maintained;
Coordinate and promptly performing any recall operations for medicinal products;
Ensure that relevant customer complaints are dealt with effectively;
Ensuring that appropriate provisions are implemented for suppliers and customers
Approve any subcontracted activities which may impact on GDP;
Self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
Keep appropriate records of any delegated duties;
Final disposition of returned, rejected, recalled or falsified products;
Approve any returns to saleable stock;
Ensure that any additional requirements imposed on certain products by International/National law are adhered to.
Education/Experience/Training Required:

• B.Sc. in Science related discipline.
• More than 5 years’ experience in this or similar role
• Comprehensive knowledge and appropriate qualification in the role of RP and experience in GDP processes and procedures.
• Able to communicate effectively with other departments, management and operational personnel.
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).

Quality Specialist (Full -Time)

Job Description:

Key responsibilities:
Support the client in obtaining and maintaining their WDA licence by acting as the Responsible Person (RP).
Manage and maintain the company’s existing quality management system (QMS).
Develop, manage, maintain and analyse Key Performance Indicators (KPI’s).
Compliance to appropriate ISO standards (ISO 9001:2015)
Compliance and knowledge to the Internal Audit program and conduct internal audits.
Review and approve documents internally and for external clients as part of RP or Quality role.
Participates or serves as lead Quality Representative on process improvement initiatives.

Education/Experience/Training Required:

• B.Sc. in Science related discipline.
• More than 5 years’ experience in this or similar role.
• Comprehensive knowledge and appropriate qualification in the role of RP and experience in GDP processes and procedures.
• Experience and knowledge of ISO 9001 standard, GMP and GDP Guidelines.
• Relevant auditing qualification, i.e. Lead Auditor.
• Experience and Knowledge of US and EU Regulations (ICH, EU GMPs, GDPs, ISO, etc.).
• Demonstrate proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, and Access); Project and Visio.

Senior Roles Based in Dublin

As part of a large project that we are carrying out on behalf of a well established global pharmaceutical company, we are seeking to identify and recruit a Head of Global Regulatory Affairs and a Head of Global Pharmacovigilance.

This is a unique opportunity to build and lead a team of regulatory specialists with a global pharmaceutical company.

Our Client Company Based in Dublin

Our client is a globally trading firm with facilities across the world. They have a well-deserved reputation as the market leader in their product category, with significant sales in territories such as the USA, Europe and Asia.
In recent years they have experienced significant success with elements of the product portfolio in a number of ‘new territories’. They have built up a large and well respected workforce in countries such as the USA, Canada, China and elsewhere.

The Future

The successful candidate will be tasked with developing and implementing a global regulatory strategy to enable the company to maximise their revenue in their target markets. The Head of Global Regulatory Affairs will lead a team of in-house specialists and external consultants to ensure that our client company can continue to grow their business.

Remuneration

The successful candidate can expect a market leading salary and benefits package. As this is a new role, we, along with our client, are willing to tailor a package to best suit the needs of the role holder.

The Head of Global Regulatory Affairs (GRA) will establish the centre of excellence for regulatory affairs with the aim to drive efficiency across regulatory functions. The role holder will drive the design and implementation of strategic and tactical process change initiatives in a manner that creates consistency and efficiency.

The role holder will be responsible and accountable for all operational activities including training, budget and special projects related to the daily activities of GRA. He/she will oversee and ensure overall compliance within GRA.

Head of Global Regulatory Affairs

Principal Responsibilities

• The Head of Global Regulatory Affairs will create vision, strategy and goals for achieving operational excellence within. He / she will identify operational gaps in execution, prioritize, plan, and drive cross functional projects within agreed timelines
• Oversees, coordinates and executes the GRA accountabilities
• Owns the budgetary responsibility for Regulatory Affairs, prepares department budgets and identifies appropriate external resources as needed
• Ensure that each project initiates with clearly articulated ‘terms of engagement’, has well defined and measurable business results, and is delivered on-time, on-budget and within scope
• Accountable for ensuring training is adequately assessed and performed within GRA
• Ensure that regulatory activities are supported by robust procedures
• Provide expertise across global regulatory teams to ensure most efficient processes are implemented and followed
• Work with the board of the company to identify and manage new regulatory projects
• Develop SOPs and processes for GRA
• Ensure that the regulatory department has/maintains up to date knowledge to meet all country and region-specific regulatory requirements
• Responsible for operational excellence and continuous improvement
• Establish, develop and manage internal talent ensuring a balance between internal resources and use of external vendors to ensure flexibility in the delivery of simultaneous submissions globally

Qualifications

• Experience in the pharmaceutical industry with 10 years regulatory affairs management experience in regulatory operations
• Experience of managing staff in a global matrix organization
• Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment
• Strong communications skills: oral, written, with proven negotiation skills, and time-management
• A critical logical thinker with the ability to analyse problems, identify alternative solutions and implement recommendations for resolution
• Sound understanding of information management concepts and tools needed to carry out Regulatory Operations priorities
• A proven ability to work under pressure and adhere to deadlines

 

Head of Global Pharmacovigilance

 

Responsibilities

  • Assume responsibility as the EU Qualified Person for Pharmacovigilance (QPPV) with overall responsibility for the safety of the company’s products.
  • Ensures the establishment and functioning of the company’s pharmacovigilance system
    To provide guidance for the development of global Pharmacovigilance strategies.
  • Provides oversight to the creation, assignment, implementation and closure of CAPAs with PV association.
  • Establish and ensure continuous improvement of global, regional and local PV procedures.
  • Ensures tracking tools (e.g. for local Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Individual Case safety Reports (ICSR) are accurately maintained.
  • Maintains compliance oversight of PV activities undertaken and delivers month compliance report to upper Management.
  • Supports negotiations with health authorities and supports the review and submission of responses to regulatory agency questions, PSURs and RMPs and local risk minimization tools as needed.
  • Manages regional communication network; lead monthly calls with local officers, maintain lines of communication with stakeholders including regional/country officers RA, QA, clinical, legal and commercial partners.
  • Assure oversight for the medical review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
  • Ensure the on-going evaluation of the overall safety profile for client products, working in partnership with the client’s partners to bring potential safety issues to the attention of upper management and health authorities as appropriate.
  • Reviews commercial agreements provided by Legal/ Commercial (where new are needed) and ensures appropriate level of cover is detailed in Pharmacovigilance Agreements (PVA) using approved template and meet local reg. requirements.
  • Accountable to ensure local and global literature searches are performed by 3rd party partners.
  • Provides oversight of all PV Inspections/audits/CAPAs and local remediation plans in collaboration with PV Team.
  • Provide input to PV Training & evaluation standards.
  • Maintains awareness of local PV Regulatory requirements & implementation plans.
  • In-direct functional oversight of Distributor personnel with responsibility for PV activities.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written).
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Demonstrated experience of proactively driving a team in a variety of tasks, projects and team management.
  • Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds.

Qualifications

  • Degree in Science (MSc, PhD, MD) with further qualification/certification in project management methodologies and/or change management.
  • Minimum 10 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization.
  • Understands and maintains strong working knowledge of PV global regulations and guidelines with an excellent PV operational knowledge. Knowledge of Regulatory processes is an advantage.
  • Experience of working with CROs, vendors, and relationship management preferred.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.

How to Apply For Any Of These Open Vacancies

These roles are being managed exclusively by Acorn Regulatory.

If you would like to have an initial confidential discussion regarding the latest regulatory affairs vacancies then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706.

Alternately, if you would like to submit your up to date CV for consideration, then please email: b.p.cleary@acornregulatory.com