The International Regulatory Strategy Product Lead is responsible for defining the regulatory strategy for assigned products covering International markets (APAC, LATAM, EAMEA, and Japan) and providing regional regulatory expertise.
The individual is responsible and accountable for executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of Shire products in the International markets as dictated by Shire business objectives. This will include interacting with the international team and distributors (where needed) to ensure timely submission and approval for Shire products in these markets.
About the position:
- Responsible and accountable for defining the International regulatory strategy for assigned products (maintaining and extending Shire product registrations in International markets).
- Collaborates closely with all other key GRA stakeholders (including but not limited to Global Regulatory Lead, labeling, CMC, regulatory operations, EU regulatory team and regulatory staff in the local operating companies) to ensure that all aspects of the regional strategy is coordinated and considered.
- Designs international regulatory strategy for products that they are accountable for in close collaboration with the GRL to obtain, maintain and extend Shire products registration in the international markets
- Ensure international strategy is appropriately represented within the Global Regulatory Team and at other appropriate forums (Late Stage Project Team, Global Development Team etc.) through the GR Lead
- Provides regional regulatory expertise to the GR Lead and within GR Team
- Works in close collaboration with the GR Lead and International operating companies in providing support to meetings with Health Authorities (where needed).
- Potential to mentor junior members of the regulatory team as required by the business.
- Leads cross-functional submission teams to ensure creation and submission of qualitative regulatory documents within defined timelines as per company objectives
- Acts as International regulatory strategy lead for all applications conducted in the International region, coordinating with the assigned Clinical Research Organisation (where appropriate) and functional stakeholders to ensure the timely submission, approval and compliance of all applications.
- In collaboration with cross-functional team, ensure timely updates to product core dossiers for the assigned products
- Communication and collaboration with all relevant international stakeholders to ensure they are fully informed of all activities with the regions.
- Ensures that regulatory submission and approval notification is communicated to appropriate functions within the defined timeframe to allow implementation.
- Ensure appropriate archiving of all submissions performed on international market
- Collaboration and support to International LOC team for the review, approval and implementation of regional labeling.
- Ensures documentations like Labelling tracker and Product History templates are updated in a timely manner (where needed)
- Work closely with International LOC in ensuring that artwork (e.g. request for mock-ups) to support product registration is generated on time
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel,
- Provides support to GXP inspection activities as required.
- Ensures all regulatory documentation is stored within Shire systems / databases in accordance with Shire standards
Skills you need:
- A degree in life sciences
- Strong experience in drug/biologics development either within the pharmaceutical and biotechnology industry or Government Health Agency,
- Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred
- Knowledge of International regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals.
- Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
- Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in International region. Prior experience and a track record of success in working with International partners
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Must be comfortable with performing operational aspects of regulatory affairs like managing module 1 requirements by collaborating with International local operating companies and collaborating with International LOCs on artwork requests supporting regulatory submissions.
- Working in a matrix structure and with cross functional teams, requiring strong negotiation and influencing skills.
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 4.225,44 gross per month (full-time); increased payment is highly likely. We are looking forward to your application!