Regulatory Affairs Specialist – Labelling

Biopharma Careers; India; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs professional to provide operational and regulatory support for ANZ submissions, manage RIM databases, and assist with artwork changes for global and local initiatives in Australia and New Zealand. The role involves collaboration with stakeholders to ensure timely registrations and post-approval commitments, with a focus on quality and regulatory compliance.

The position emphasizes regulatory IT projects, SOP updates, and continuous improvement, requiring

Qualifications

• Graduate with experience in pharmaceutical industry.
• Attention to detail and ability to manage multiple projects.

Responsibilities

• Prepare variation submissions and artwork changes for HA requirements.
• Maintain and govern artwork style guides and QA submissions for ANZ.
• Support Regulatory Affairs in dossier development and post-approval activities.

Skills

Regulatory affairs

Artwork review

Documentation management

Regulatory reporting

Stakeholder liaison

Job description

## About this opportunity**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!Provide effective operational and regulatory support to ensure compliance and regulatory submission activities for ANZ, effective regulatory reporting on submission, HA questions and approval status and follow on activities including continuous improvement in relation to standards, templates and pro-cedures.Regulatory Information Management (RIM) on relevant systems, trackers and databases for regula-tory submissions and commitments.Provide support to the artwork team for global and local initiatives for the Australia and New Zealand market to allow the best possible time frame for registration and launch/supply continuity.Partner with relevant stakeholders to assist in achieving optimal company outcomes.**Job Description****Your Key Responsibilities:**Your responsibilities include, but not limited to:**1. Regulatory Team Support**Prepare variation submissions, incl templates for artwork changes in partnership with theRegulatory Affairs Submission Team in the required timeframeSupport the creation, maintenance, and governance of artwork style guides across all marketed dosage forms, supporting private label, mature brands, biosimilar, prescription and OTC portfolios, ensuring compliance with HA requirements and internal initiatives such as QR codes and serializationConduct 2nd review of artwork briefs and updates to ensure compliance with HA requirements and internal Artwork style guide prior to artwork creation by external agencyAccountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments.Ensure key submission and post approval activity data provided by RA is up to date and accurate. Ongoing review of tracking metrics to identify areas of improvement.Assist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs.Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.Ensure systems and processes are in place to enable regulatory history for all applications is traceable and regulatory documents are easy to locateEvaluates proposed changes and provides functional input and update for affiliate regulatory actions and impact.Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting.Liaison with international parent and license companies, third parties for the acquisition of documentation, information and responses to issues raised during review/evaluation. Create and maintain databank of frequently asked questions to improve dossier quality. Update RIM to enable SMEs to provide quality and timely responses to Health Authority questions.Contribute to the Regulatory Affairs Department initiatives e.g. process improvements, implementation of new technologies, audit readiness, digital readinessProvide input on future Regulatory IT projects both on a local and global basis as required.**2. Artwork Team Support**Support the regulatory submissions team on artwork related activities with input from relevant Regulatory Affairs Associate to ensure continuity of product supplyCreation of Artwork change requests; perform data maintenance and implementation tasks;liaise with internal and external stakeholders for timely implementation of updated artworks;\">liaise with internal and external stakeholders for timely implementation of updated artworks;\">undefinedGenerate artwork briefs for new submissions and variations according to HA requirements and internal AW style guideSupport RA and Artwork teams with the execution of tasks within the artwork approval system, (generating annotations, uploading documents, document review and document approval) as required**3. Other Activities**Contribute to continuous improvement activities such as revision of SOPs/WIsThe position will also assist the Director of Scientific Affairs or their nominee on tasks as required.Keep up to date with current overseas, Australian and New Zealand regulatory requirements and how these affect the Sandoz pipeline and product portfolioProvide strategies for internal projects, and continuous improvement via knowledge sharing.**Ways to Measure Accomplishment**Regulatory submissions are submitted in accordance with global/local procedures. Regulatory submissions information is updated and archived in accordance with global and local filing and archiving SOP; ARTG details reflect registered detailsDemonstrate all aspects of local SOPs and related documents are practiced by the teamEvidence of regular training on local SOPs and related documents.Local and global stakeholders are kept updated on progress of application, in order to support product supply as defined by customer feedback and compliance with local best practiceRegulatory input for databases is provided to enable effective change managementPost-approval commitments are adequately tracked, communicated, and completedObjectives and timelines of assigned departmental projects are metActive participation in departmental meetingsAppropriate level of sharing on expertise and knowledgeActive contribution to HA and industry consultation processesDevelop and implement local strategies to manage regulatory riskWhat you’ll bring to the role:Essential Requirements:Graduate with experience in pharmaceutical industryMinimum of 2 years industry experience desiredStrong attention to detail; thorough preparation of documents.Ability to work on multiple projects simultaneously and change direction quickly.Demonstrate ability to access information from multiple sources.Ability to support other members of the team.Some knowledge of TGA and Medsafe requirements.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