Job Description
Our client, an international pharmaceutical company based in Dublin, now seeks a Senior Manager, International Regulatory Affairs for Lifecycle Management and team/fuction management. This role will have office presence in Dublin team, however there is also flexibility to work from home some days per week.
As a member of the Senior Management team, this hire will work with other stakeholder (such as Commercial, Marketing and Finance) in developing strategy plans for new initiatives to ensure the timely entry of new products to global market and the ongoing success of existing products.
This hire will provide the planning and leadership to the Regulatory Department by ensuring that appropriate structures, systems and values are developed. Additionally, ensuring that an appropriate infrastructure is in place to support the Marketing Authorisation responsibilities as defined in Directive 2001/82, Directive 2001/83 and as required for third country registrations.
The successful candidate will represent the company for Competent Authority / Ministry of Health interactions including but not limited to attendance at Regulatory Authority meetings, Scientific Advice meetings, Quality Defect notifications, Recalls and Inspections.
The ideal candidate will be a highly experienced Regulatory Affairs Manager, who has a mix of experience in large and small pharma/biotech companies, and who is adaptable to a demanding, changing nature of a busy environment.
Responsibilities for Senior Manager, International Regulatory Affairs - Lifecycle Management:
Ensure that the interfaces between Regulatory and other departments are managed optimally.
Collaborate with marketing on product promotional plans and representative training activities and ensure regulatory compliance for promotional/non-promotional materials including websites and product information to HCPs and patients where required.
Provide updates to the business on regulatory developments periodically.
Identify and assess regulatory risks associated with the registrations and/or licences and define strategies to mitigate risks.
Have responsibility for the financial management of the regulatory budget.
Provide product specific strategy, technical/subject matter expertise and coordination oversight for key projects as required.
Provide pre- and post- market regulatory support to ensure regulatory compliance and optimal and compliant product life cycle management.
Maintain manufacturers authorisations (standard/IMP), marketing authorisations (product licences) and other regulatory documents, as required.
Oversee the preparation of regulatory documentation and submissions.
Keep up to date with regulatory international legislation, guidelines and customer practices.
Ensure the preparation, approval and maintenance of department SOPs.
Developing and implementing the Quality department’s strategy, to ensure it meets the business requirements.
Implementing and monitoring all QA systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use.
Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.
Acting as the main point of contact on all Quality matters, internally and externally.
Ensuring the development of departmental SOPs, ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
Preparing, reviewing and approving Technical and Quality Agreements.
Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action.
Oversight of the development of regional artwork processes with close liaision within Commercial, Regulatory and manufacturing site.
Ensure all product labels and leaflets (artwork) for consistency with the licence for implementation according to required timelines.
Ensure that design and regulations requirements for each new product, new pack or changes to existing packaging and compliant with local requirements.
Requirements for Senior Manager, International Regulatory Affairs - Lifecycle Management:
Bachelor of Science Degree in Chemistry, Pharmacy or related Life Science discipline. Advanced qualification is preferred.
Minimum 8+ years applicable Regulatory Affairs experience in the pharma/biotech industry, 3+ years people/team management experience in this discipline.
Excellent knowledge of global, regional, national country requirements, regulatory affairs requirements for licensing and life cycle management.
Demonstrated track record of success building relationships with, and influencing, regulatory agencies, particularly in situations requiring direct interaction/negotiations.
Demonstrated experience in motivating and integrating teams and teach/mentor team members.
Demonstrated experience in discipline and reward employees and perform timely, effective performance evaluations.
Excellent organizational and planning skills
Expert knowledge of ICH and other global regulatory guidelines.
Knowledge of budgeting and forecasting
Excellent interpersonal skills and proven ability to work in team environment.
Effective oral and written communication skills.
Good negotiation skills
Proven leadership skills
Please phone Larry on +353 (0)1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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