Would you like the opportunity to work in a dynamic, young environment? Are you interested in your personal growth, as well as your career’s?
is an IT services, consulting, and business solutions provider that has been partnering with the world’s largest businesses in their transformation journeys.
1. Primary Responsibilities
● Primary focus is on the EU Annexes process for Centralized Procedure, PALC (pre-accession linguistic review), Article 61.3 Notification
● Product responsibility is mainly for marketed products
● Supports and provides coordination, compilation and publishing expertise in the preparation of EU Annexes for submission, following procedure and translation timelines set by the EMA, in compliance with EMA/QRD/NCA regulations; keep EU Affiliates informed of each step related to an EMA procedure via EU Annexes TouchPoint site
● Coordinates QRD formatting check and logic check of translations, and final PDF preparation, ensuring quality and completeness
● Ensures English EU Annexes and their translations are compliant with EMA/QRD guidelines for incorporation into eCTD closing sequence submission
● Monitors EU Community Register website daily for EU Commission Decision and notifies stakeholders when the decision is posted; compares English version to identify any changes made by the EU Commission
● Publishes the English EU Annexes Commission Decision version in PID (product information dissemination) and informs stakeholders
● In collaboration with internal Roche SME (subject matter expert) Informs and supports training of Submission Managers on new EMA requirements and activities related to the EU Annexes
● Liaises with PDR Program Management, Artworks, EU Affiliates, other cross-functional internal teams/team members and external partners or vendors; helps facilitate communication and collaboration to meet translation and submission timelines and plan future requirements.
● Where applicable, may participate in local Filing Team meetings, providing ongoing expertise, guidance on compliance, timing and other relevant matters related to EU annexes
● Participates in site and/or global PDRO departmental meetings
● Stays abreast of internal and external developments, trends and other dynamics relevant to EMA/QRD requirements for EU product information labelling
● In collaboration with internal Roche SME, contributes to development and maintenance of guidance documentation for PDRO related to the EU Annexes
● May participate in project planning to ensure EU Annexes submission requirements and timing are in alignment with overall project timelines
● Bachelor Degree in Lifesciences preferred
● Relevant experience in regulatory affairs or related functions is strongly preferred; previous experience supporting related activities is a plus.
● Demonstrated ability to prepare electronic and non-electronic submissions as required by regulatory and departmental guidelines for submission to health authorities.
● Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, relevant publishing and document management systems/software
WHAT DO WE OFFER?
In our Shared Service Center you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.
This position belongs to the BPS (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations.
As a future TCSer, you will be provided with:
- A career path that will allow you to become a Subject Matter ExperGet trained on various competencies and skills
- A great diversity of cultures
- Language courses and training
- On-site relax & gym rooms
- Volunteering, sport and employee events