Shire EU Regulatory Strategy Product Lead (m/f) in Vienna, Austria
The EU Regulatory Strategy Product Lead is accountable for defining the regulatory strategy and providing regional regulatory expertise for his / her product(s). The products can include both early development and life-cycle assets.
The individual is responsible for defining and executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of Shire products in the EU and Switzerland as dictated by Shire business objectives. This will include interacting with the EMA and national Regulatory Agencies in the EU Member States as needed to ensure timely submission and approval for all applications that are required for Shire products in these markets.
About the position:
Accountable for defining the EU regulatory strategy for assigned products (maintaining and extending Shire product registrations in EU markets). Collaborates closely with all other key GRA stakeholders (including but not limited to, labeling, CMC, regulatory operations, international regulatory team and regulatory staff in the EU LOCs) to ensure that all aspects of the regional strategy is coordinated and considered.
Under direction of EU Regulatory Strategy Team Lead, designs EU regulatory strategies in close collaboration with GRL to obtain, maintain and extend Shire product registrations in Europe.
Provides regional regulatory expertise and works in close collaboration with the GRL in organizing and providing support to meetings with European Health Authorities. For the majority of the Agency meetings, the Product Lead will chair the EU Agency meetings.
May have the opportunity to mentor junior members of the regulatory team, including providing guidance to the EU Product Strategy Specialists.
Leads and chairs cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
Acts as regulatory lead for CTA applications conducted in the European region, coordinating with the assigned CRO and functional stakeholders to ensure the timely submission, approval and compliance of all CTA applications
Ensure appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency and other regulatory agencies in the EU member states to ensure the regulatory applications are approved in a timely manner
Ensures that the approval is communicated to appropriate functions to allow implementation
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and remains in compliance with all current Shire trainings and internal processes,
Provides support to GXP inspection activities as required
Ensures all regulatory documentation is stored within Shire systems / databases in accordance with Shire standards
Communication and collaboration with the EU LOC team to ensure all parties are informed of all activities directly affecting their market
Skills you need:
Experience in biologics, clinical development, drug safety, pharmacovigilance and/or risk management preferred
Minimum of 5-7 years experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency
Knowledge of EU 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 EU region. Prior experience and a track record of success in working with EMA & national agencies in the EU is required
Ability to work independently to propose solutions to complex problems, taking into consideration external factors (e.g commercial implications etc) that would be impacted by the decision
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
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. at https://youtu.be/ly_8oO-iJeU
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 in Austria (where we are legally required to mention the minimal salary) is € 4.094,41 gross per month (full-time); increased payment is possible. Other locations will have different salary ranges. We are looking forward to your application.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.