Regulatory Affairs Senior Lead

Regulatory Affairs Senior Lead

Work type: Remote Working

Start Date: ASAP

Contract Duration: 12 months

Weekly Hours: 37.5

Hourly Pay Rates: £70 - £80 PAYE 

This role falls inside IR35

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Job Description:

Our EMEA emerging markets RA group ensures optimal strategy across EMEA Emerging Markets countries and compliant life cycle portfolio management.  Partnering across the globe, region, and functions, we focus on interlinking global ways of working and efficiencies with specific EMEA EM needs dedicated to deliver a compliant reliable medical product in the geographic scope of EMEA emerging markets including commercial and GPH work scope.

The EMEA Emerging Markets Operational Excellence lead  reports to the Senior Director (SD), Reg Affairs EMEA EM / GPH who is accountable for the Regulatory Submission strategy, RA Compliance and RA Continuous Improvement within the market scope. This leader will establish and sustain a solid framework for the EMEA EM and will conduct & manage Continuous Improvement (CI) Projects and Strategies for the cross-TA portfolio (commercial & GPH) and will ensure full support in all aspects of operational excellence and CI to EM network in several areas.

Main activities:

• Provides support to the EM network for proper execution of the regulations enforced by HA Health Authorities. This includes LOC Clusters heads and their reports.
  • Acts as a LOC liaison and delegate for the Senior Director head of EM as appropriate 
  • Problem solver coach for LOC RA team with decision making mandate as required
• Contributes to maintaining and disseminating the regulatory activity metrics and intelligence foundation and framework that establishes a systematic approach in implementing new regulations in liaison with the EMEA EM RA projects Manager
• As required, manages, leads, executes continuous improvement projects within RA which could be providing cross functional subject matter expertise or directing EM, GPH projects within RA in liaison with RA EMEA EM PM
• Contributes and/or leads Regulatory input into business development projects
  • To this end develops the SMEs who will provide the support 

Continuous Improvements

• Independently manages, plans, and directs all aspects for the successful design, sponsorship or lead of RA business support improvement or excellence side initiatives which are additional to those managed by team PM. Ability and mandate to make strategic decisions as the delegate for EMEA EM RA head for both commercial and GPH scope. 
• Development and deployment of standard work for Continuous Improvements across the EMEA EM RA network by utilising organisation’s available toolkits at our disposal to assist the EM RA network with the selection of the right tools including but not limited to operational excellence and Compliance and to enable effective and efficient submission execution and life cycle management
• People focus develops and sustains the EM RA network who create and execute the Continuous Improvement Side Initiatives across the region and across TAs. This could also apply cross functionally within the EMEA EM. Support team PM and LoC teams as required as a delegate for Sen Dir.
• Adds value to enhance productivity in all aspects of regulatory activities in the region.
• Supports as necessary the  generation and monitoring EMEA EM RA Metrics and ensures proper visibility and communication to all the required stakeholders
• Provides support to SD in senior management reporting as required
• Supports the SD in the development of the future state staffing model for the team to support the business needs and in alignment within the EMOC & GPH LRFP and GRA strategic refresh as needed.
• Provides coaching and mentoring for staff, assesses any gaps in the team and develops action plans to address the gaps including diverse and inclusive staff development

  Strategic Initiatives 

• Stays current with regulations / guidance in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximise the positive outcomes of the regulatory applications and maintain registration compliance.
• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams, company’s consultants and Business Partners.
• Could be asked to evaluate new business development opportunities for Emerging Markets and / or participate on due diligence teams.
• In coordination with local regulatory lead and EMRL provides strategic guidance / advice on emerging trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs e.g. external shaping obo of the Sen Director – as delegate
• Manages, trains, provides direction, strategic guidance and solutions to projects to direct and indirect reports and / or mentors team members, if required, to support scope of project work.
• Partner with the LOC RA colleagues, regional/LOC market access and launch excellence team to understand end to end pharma value chain topics and support opportunities to drive consolidated inputs into regional product development plans.

Compliance: 

• Works with EMEA RA compliance director to ensure regulatory compliance EM- GPH Support 
• Identifies and develops the SMEs accountable for providing supports in continuous improvement projects and compliance matters and implements regular trainings available to the global teams to ensure building knowledge base re the EMEA region for commercial and GPH scope regulatory activities with particular support to LOC teams
• Support on local RACI and ways of working to provide best interest cross functionally and for RA.
• Could contribute or lead if needed , any integration projects between GPH and EMEA EM commercial RA ways of working to find efficiencies and operational excellence across clusters and TAs.
• Acts as delegate for Sen Director in the role of EMEA EM Regulatory Representative and decision maker on the LISC (Labelling Implementation Steering Committee for MEWA pack)
• Acts as delegate for Senior Dir.  As required on compliance topics such as QIs, escalations, CAPA  in terms of mentoring and decision making.
• Acts as a delegate for Senior Dir in organising LOC or EMRL representation or participation in GRA projects or initiatives and cross functional projects or initiatives. May act as a project sponsor obo Sen Dir.

Regulatory Intelligence (RI): 

• Ensures that the RI systems will consistently convey & collect the internal stakeholders’ feedbacks on the new draft regulations to ensure EM best stance with the new regulations with the impacts our products and manufacturing processes
• Directs and educates as necessary the global and regional RA teams in deploying understanding of the regulatory framework in the region

Requirements

• Education Bachelor or master’s degree in an appropriate scientific field of study | Preferred fields of study include Pharmacy, Biology, Chemistry, Business at master level 
• Ten (10) years of work experience in regulatory roles within the pharmaceutical industry 
• Good business acumen
• Strong knowledge of Health Authority regulations (EMEA with focus on EM and associated complexity), cGMP, ICH, and other  
• Experience with continuous improvement, change management and business process reengineering, principles of Six Sigma and lean practices or general project management.
• Ability to effectively apply risk management and mitigation principles in ambiguous situations
• Ability to work effectively in a diverse global environment with colleagues at all levels of the organisation
• Advanced proficiency in written and verbal communications in English 
• Demonstrated leadership, influence, and people management skills, including interactions outside of formal reporting lines in a matrixed organisation

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 1 - 2 working days.
• We do not accept applications via email.

If you are interested in this role please click on the link below to complete your application. Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application!

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.