Shire Nordics-Baltics Regulatory Affairs Specialist in Vilnius (Baxalta), Lithuania
The Regulatory Affairs Product Specialist provides regulatory strategic support for Shire product portfolio within the local business/operating company (LOC), primarily the Baltic countries, but also support with regulatory tasks for other Nordic countries. Primary responsibilities include operational regulatory affairs activities, involving interface from LOC to European and Global RA, ensuring conformance to national and EU Drug Laws, maintaining labeling information to internal and external partners, communicating with regulatory authority and regulatory institutions if required in collaboration with EU strategists, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams, coordinating activities and communication with regulatory consultants. Approval of specific advertising and promotional materials in accordance with national legislation and codes of practice. Responsibilities include ensuring adherence to company standards and local laws.
National Regulatory authority interactions:
LOC manages direct interactions with Baltic regulatory authorities for national licenses and facilitates interactions by the EU RA strategists in the case of European procedures.
Regulatory contact point for local, international and global cross functional teams on all regulatory matters:
Acts as country RA Specialist with primary national regulatory responsibilities for the Baltic countries (EE, LT and LV) for all product franchise(s), and serves as regular back-up for other country RA Nordics Baltics when applicable.
Submit applications to national authorities* in the Baltics, in liaison with regulatory consultants if applicable, for products approved in the national procedure, and for the national phase for products approved through MRP and DCP, where applicable.
Provide regulatory advice and assistance to support the Baltic LOC strategy for relevant product franchise(s).
Ensure labelling implementation in the Baltics, such as notification to business teams, update of external websites and compendia, in line with internal procedures and external requirements.
Ensure in conjunction with the Nordic-Baltic Regulatory Lead that regulatory requirements of the Baltic region are fully represented in discussions at Global, Regional and Local levels.
Support and align with other departments/functions on needs re periodical requests (e.g. tender support and P&R submissions).
Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements*.
With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors.
Clinical trials applications, if applicable:
Submission of PASS protocols to the national regulatory authorities.
May be involved in clinical trial submissions for interventional company sponsored clinical trials
Scientific advice meetings
- Facilitate preparation for scientific advice meetings with national agencies.
Launch readiness and other commercial project team support as country RA Specialist for Baltic countries.
Provide regulatory input to Health technology appraisal/ horizon scanning for product portfolio, when applicable.
Product support for tender and pricing application, if applicable.
Provide regulatory guidance and support of Early Access of Medicines (Named patient use, compassionate use etc.)
- With PV proactively assess any Risk minimization activities, review educational materials and engage with national regulatory authorities* to gain approval of Risk minimization measures / educational materials.
AdProm (CMLR) review:
Participate in local review teams and work to local regulations / requirements/codes and Policy for the*:
Review of promotional materials and patient support materials on Shire products according to applicable national advertising law and applicable codes of practice and in line with SOP, WI and LIP
Coordinate the creation and maintenance of abbreviated prescribing information (API) for new and marketed products*.
*) Ensure appropriate contract and oversight is in place in case such activities are delegated to external regulatory consultants.
Proactively monitor national regulatory landscape :
Develop professional and effective working relationships with Baltic national regulatory agencies.
Monitor the status of competitor marketing authorizations as agreed with local business.
Responsible for providing the consolidated feedback regarding the text translation from the relevant functions in the affiliate and regulatory consultants* to the EU Regulatory Strategists/Global Labelling team.
Management of artworks - centralized, MRP/DCP and national products: review and approve artworks*.
Responsible for updating all relevant national external databases.
Liaise with marketing and commercial to ensure that all local product information used are up to date.
On behalf of the MAH:
Ensure regulatory compliance in country in accordance with local regulations and Shire SOPs
Provide advice* to LOC team, International Commercial, on maintaining compliance of Shire activities and materials with local regulations/requirements codes at any International symposia/conferences to be held in Baltic countries
Responsible for bringing to the attention of R&D Compliance/Quality Assurance any planned local SOP or local SOP revision, which they are aware of, and which relates to R&D activities
Responsible for immediately notifying R&D Compliance/Quality Assurance of any planned health authority inspection relating to R&D activities and will work with R&D Compliance/Quality Assurance to prepare for the inspection, receive/host the inspection, and respond to findings
Education and Experience Requirements
Bachelor’s or Master’s degree in Pharmacy or equivalent
Minimum 5 years’ experience of Regulatory Affairs or equivalent experience within a pharmaceutical company, CRO or similar organization.
Key Skills, Abilities, and Competencies
Excellent communication skills and good ability to work in teams
Professional, flexible and result oriented
Ability to understand and implement regulations
Strong Negotiation skills
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Complexity and Problem Solving
Works independantly under general direction only. Work is reviewed upon completion for adequacy in meeting objectives. Exercises good judgment within generally defined practices and policies in selecting methods and techniques.
Manage multiple projects and deadlines
Ability to identify compliance risks and escalate when necessary
Internal and External Contacts
Internal functions such as QA, PV, Medical Affairs, finance, supply chain and logistics.
Internal business/franchise teams (product managers, sales managers)
Other Job Requirements
Ability to travel when necessary.
Language Skills: English (excellent spoken & written) and Baltic language (native speaker). Russian is a plus.
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.