Submission Publisher (Pharma Regulatory Affairs)
Are you a Lifescience graduate interested in pursuing your career in pharma regulatory affairs? If you are, read on, we have a great opportunity for you to support one of the world's most prestigious pharma companies.
As our new Submission Publisher, you will be part of a multicultural team helping regulatory publishing activities to ensure regulatory compliance. We want to help you develop your career in a global environment while contributing to health safety.
In our Life Science Department, you will work within the Client organization, in the Regulatory Affairs Operations Regional department (EMEA Region).
HOW WILL YOU MAKE AN IMPACT?
- Perform Submission publishing activities for different regions with applicable dossier formats.
- Perform the required activities within established timelines with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.
- Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists.
- Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions.
- QC electronic and paper submissions to ensure compliance with company and agency requirements.
- Provide component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing).
- Maintain effective interactions with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components.
- Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing.
- Support regulatory submissions publishing MRP, DCP, CP and National filing for the EU.
- Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region.
- Regular interaction with internal and external stakeholders like Local Affiliates.
ARE YOU A GOOD FIT?
- Masters or Bachelors’ Degree in Life Sciences or Pharmacy
- 6 - 12months of experience in submissions for EU regions
- Experience in submission publishing tools like Insight Publisher and other leading electronic publishing tools
Good to haves:
- Able to work independently, guided by procedures, with appropriate support.
- Able to work effectively as part of a team.
- Attention to details.
- Excellent interpersonal and communication skills.
- Ability to prioritize, schedule and organize.
WHAT DO WE OFFER?
In our Shared Service Center you can taste the world by working together with 99 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 Expert
- The opportunity to work on different Finance and Accounting (F&A) management processes across different industries
- Get trained on various competencies and skills
- A great diversity of cultures
- Language courses and training
- On-site relax & gym room
- Volunteering, sport and employee events
Apply via "Jelentkezem" button underneath!
- Healthcare, Pharmaceutical Industry
- Healthcare Specialist
- 1-3 years professional experience
- College degree
Required language level:
- English (higher advanced/fit for negotiation)
- Full time