Regulatory Affairs - Sr. Specialist
Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to:
- Country Lead for Regulatory Affairs Ireland reporting into the UK Executive Director PV/RA.
- Has the overall responsibility for Regulatory Affairs in Ireland and for managing related issues according to NewCo ethics and standards.
- Has line management of the regulatory group in Ireland and provides clear leadership for the group.
- Manages the departmental workload and ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the HPRA/EMA.
- Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- For assigned products ensures timely, accurate and compliant labeling and artwork preparation.
- Stays updated on NewCo filings, relevant EU and local regulations and guidelines. Designs and implements regulatory ad-hoc local action plans, as necessary.
- Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the business to support business initiatives in sub region.
- Maintains a positive relationship with internal and external regulatory contacts. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
- Provides regulatory advice as appropriate.
- Acts as primary point of local regulatory agency contact for the company in case of any urgent regulatory agency requests.
- Administers the departmental budget, manages HPRA fees
Major activities include, but are not limited to:
New MA applications for assigned products:
- Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
Maintenance of licenses for assigned products:
- Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
- For major indications, designs and implements local action plans as required.
- For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to NewCo and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
- Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
- Ensures the correct and proper utilization of artwork management systems to generate mockup artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Labeling and artwork:
- Ensures high quality QRD check of Summary of Product Characteristics and Patient Package Leaflets.
- Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
- Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
- Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
- Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
- Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
- Keeps abreast of local and international laws.
- Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders.
Manage RA Team:
- Set performance and development objectives for direct report Regulatory Affairs Specialist and monitor and guide them in achieving them. Appraise staff formally at year end and as necessary informally throughout the year.
- Review and advise on staff training and education needs. Manages, coaches, and develops talent
Skills Required: Must hold a degree in pharmacy or other life science. A minimum of 5 years experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies. The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products. This is a leadership role in a small team and supervisory or managerial experience would be an advantage..
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client oriented approach and work according to the NewCo leadership vision.
Who we are …
We are a global biopharmaceutical leader with a diverse portfolio of rescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.