Reg Affairs Specialist; Documentation

23 hours ago

Telangana Sandoz, India Sandoz Full time ₹ 25,00,000 - ₹ 70,00,000 per year

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape

The Global Labelling Team supports worldwide compliance and maintenance of global labelling documents for generic marketing authorizations. The main purpose of this team is to ensure that the Company Core Data Sheet (CDS) and core English SmPC/PIL/labels are maintained and kept up to date according to latest scientific knowledge and communicated to relevant internal stakeholders and HAs as required.
In scope: Medicinal products (Generics) within Sandoz portfolio
The Global Labeling Specialist is responsible for the maintenance of regulatory compliant, competitive, and up to date core labelling documents for assigned products throughout the product lifecycle in compliance with legal, scientific, ethical and administrative requirements as well as in accordance with Sandoz labelling processes and standards. The Specialist would also work with some independence in supporting Safety Label Update Managers to identify safety updates for assigned products and to ensure that the core safety information is kept up to date.
The Specialist would also be involved helping with process efficiencies of current processes in CDS updates and evaluation of information on products from various Healthy Authority and Reference Product Websites.
As needed, the Specialist would also support in Compliance tasks, Audits and Inspections under the guidance of Compliance Managers within the Global Labelling team.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Update core texts SmPCs/PLs/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals.

  • Coordinate translations for CPs. Ensure in-time hand-over of variation package or response documents to submission teams.

  • Interact with country organizations to ensure timely submission of labelling changes. Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.

  • Support to Global Labelling Managers on CDS compilation, safety label update evaluation and authoring of documents. Ensures patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of the core safety information of marketed products.

  • Checks signals in the signal management tracking system (cdsDB), including reference product information and regulatory authority communication for review of CDS and related Expert Statements.

  • Screen and maintain databases and sharepoint sites as defined within the Global Labelling Team.

  • Supports Compliance Managers in SOP management, PSMF annex preparation, deviations, Audits/Inspections and oversee training matrix. Coordinate labelling projects or specific safety tasks as assigned.

  • As needed, mentors new or less experienced team members on regulatory submissions or safety label update evaluation. Technical and administrative support to Global Labelling Managers and Head of Global Labelling.

What you'll bring to the role:Essential Requirements:

  • At least 5 years of relevant experience in Regulatory/Pharmacovigilance domain with an exposure of working in a global organization in generics is preferred.

  • Experience in managing databases; creating and maintaining sharepoints; with added skills in Excel, is preferred

  • Exposure towards project management is a plus

  • Well-structured, result-oriented, highly self-committed, resilient, flexible, team player

  • High operational excellence orientation

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported 

Join us

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

  • Reg Affairs Senior Specialist; Documentation

    1 day ago

    Telangana (Sandoz), India Sandoz Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Description SummarySandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shapeEnsures a controlled...

  • Hiring for Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India Saraca Solutions Full time

    Hyderabad **Job ID**: SS202500077 **Function**: Quality **Role**: Regulatory Affairs **Desired Skills**: Regulatory, EU-MDR, Document, International Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in...

  • Reg Reporting

    3 days ago

    Hyderabad, Telangana, India HSBC Full time

    -Job description **Business**:Magnus** **Open positions:1** **Role Title**:Reg Reporting - Transaction Testing AVP GSC’s** **Global Career Band**:5** **Location **(Country / City )**:Hyderabad / Chennai** **Recruiter Name**:Charu Jain** **Why join us?** - Assurance performs independent review and evaluation of end to end processes, risks and Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees...

  • R&d Regulatory Affairs

    3 days ago

    Hyderabad, Telangana, India PepsiCo Full time

    Overview: - This role involves supporting the Regulatory Affairs team by serving as a Discipline Approver, ensuring compliance with regulatory standards for raw material specifications. Located within the Mexico Business Services or Hyderabad Business Services, you will play a key part in maintaining adherence to regulations within the designated business...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Hyderabad, Telangana, India Medtronic Full time

    At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all You ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Supporting Design and Development Control activities with regulatory requirements direction tactics and...

  • Regulatory Coordinator

    4 days ago

    Hyderabad, Telangana, India Novartis Full time

    **Summary**: Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. **About the Role**: Key...

  • Team Lead- Medical Affairs

    2 weeks ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees...

  • Regulatory Affairs Sr Associate

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure compliance...

  • Documentation Specialist

    1 day ago

    Hyderabad, Telangana, , India USP Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our...