Regulatory Affairs SpecialistApply Now Email Me Job ID SR0036950 Date posted 07/15/2019 Location: Paris, France
The Regulatory Affairs Product Specialist provides regulatory support for Takeda products under his/her responsibilities within the local business/operating company (LOC). Primary responsibilities include:
- operational registration 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, including VD&A,
- 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.
The RA Product Specialist acts as Pharmacien Responsible Intérimaire (deputy of the Chief Pharmaceutical Officer) during his absences in accordance with articles L.5124-1, L.5124-2, L.5124-4, Article, R.5124-34, and R.5124-36 of the Public Health Code and with the related delegation letter.
- Manage direct interactions with local regulatory authorities for national licenses and for national phase of MRP/DCP procedures and facilitates interactions with the EU RA strategists in the case of Centralized procedures.
- Submit applications to national authorities for products approved in the national procedure, and for the national phase for products approved through MRP and DCP, where applicable.
- Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the local authority or review of national requirements; this support can include the participation and validation of the regulatory strategy for national dossiers.
- Monitor submission and follow-up (as needed) with local authorities in a timely manner for registration activities or PSUR submission (as needed).
- Ensure that internal local and EU regulatory sharepoints/databases are duly updated according to the responsibilities given to LOC RA as detailed in the relevant SOPs
- Ensure in conjunction with the Regulatory Country Lead that local regulatory requirements are fully represented in discussions at Global, Regional and Local levels.
- Provide the consolidated feedback regarding the text translation from the relevant functions in the affiliate to the EU Regulatory Strategists/Global Labelling team.
- Submit the translations to local authorities for national procedures and MRP/DCP.
- Update relevant local external databases when applicable.
- Liaise with marketing and commercial to ensure that all local product information used are up to date
- Management of artworks - centralized, MRP/DCP and national products: review and approve artworks.
Interactions with and support to stakeholders:
- Contribute to launch readiness and other commercial project team.
- Provide regulatory input to Health technology appraisal/ horizon scanning for product portfolio, when applicable.
- Support for tender and pricing application, if applicable.
- Provide regulatory guidance and support for local Early Access of Medicines procedures (Named patient use, compassionate use etc.).
- Provide regulatory advice and assistance to support the LOC strategy for relevant product franchise(s).
- Develop professional and effective working relationships with national regulatory agencies.
- Contributes to communications to stakeholders if applicable (e.g. communications on product recall and supply shortage).
- Monitor the status of competitor marketing authorizations as agreed with local business.
- Contribute to the review and approval of (non) standard responses documents (SRD) for Medical Information, from a local regulatory affairs viewpoint in compliance with local regulation.
AdProm (CMLR) review / review of non-promotional materials (educational and training materials, information for stakeholders):
- Review promotional materials and educational materials on Takeda products.
- Submit promotional and educational documents to local authorities if applicable and obtain approval.
- Review internal training documents for sales reps according to French sales reps charter.
- Coordinate the creation and maintenance of prescribing information (PI) for new and marketed products if applicable.
- Review risk minimization measures and educational materials, submit them to local authorities and obtain approval.
Support to pharmaceutical organization in relation with Quality Department:
- Contribute to creation and validation of SOP and deliver the associated training.
- Contribute to local implementation of Takeda quality systems;
- Review of internal and external agreements.
- Participate in approval of any subcontracted activities which may impact any pharmaceutical activity (GDP, Pharmacovigilance, medical information, advertising).
- Participate in initial and continuous training programs when appropriate.
- Support inspection and audit readiness.
Handling of Artworks:
- Participate in the creation and modification of artworks and follow their implementation.
- Review artworks according to the approved Product Information and to the EU and local regulations and approve them.
Education and Experience Requirements
- Bachelor’s or Master’s degree in Pharmacy or equivalent
- Must be registered to Section B of the French National Council of Pharmacists;
- 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
- Good knowledge of local regulatory and QA requirements
- Professional, flexible and result oriented
- Ability to understand and implement regulations
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.