Reg Affairs Senior Specialist; Documentation

Job Description Summary

Sandoz 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 shape!
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and unit customers.

Job Description

Major accountabilities: 

• Professional and timely planning/authoring/submission of regulatory CMC documents in cooperation with relevant stockholders and under minor supervision or own responsibility. 

• Compilation of drug master files and/or dossier parts and/or submission package applying agreed regulatory strategies and current regulatory trends during development, registration and product lifecycle. Ensuring technical congruency and regulatory compliance, meeting agreed upon timelines. 

• Submission of dossiers to the respective Health Authorities in line with applicable guidelines and align strategies.  

• Processing of CMC documentation related to customer inquiries in cooperation with adequate stakeholders during development, registration and product lifecycle 

• Prepare CMC responses to health authority questions during development, registration and product lifecycle 

• Review regulatory CMC documents if sufficient level of information enabling Sandoz as MA holder to take full responsibility for the quality of the medical products and quality control of the active substances including control of mutagenic impurities as per ICH M7 guidelines. Review if sufficient information on the manufacturing and control is given and starting material designation is performed in line with the requirement of the ICH Q11 guidelines and ICH Q11 Q&A documents. Compile technical assessment in line with Sandoz procedure including identify gaps and follow up with relevant tack holders.  

• Under minor supervision, determining regulator impact for changes in chemistry, manufacturing, and controls (CMC) information to approved/submitted documents. Identify the required documentation to meet the respective health authority regulatory guidelines. Professional and timely coordination submission of related regulatory CMC documents to support business continuity.  

  Generation under supervision internal regulatory guidance documents and SOPs within assigned projects 

• Establish and maintain sound working relationships with colleges, partners and customers. Provide regulatory guidance, under supervision to cross-functional teams, and determine regulatory impact for changes in chemistry, manufacturing, and control procedures. Support global regulatory projective/indicatives. Lead regulatory projective/indicatives with supervision.  

  Develop up-to-date regulatory expertise through continuous education. Responsibility for transfer of knowledge and experiences to the organization.  

  Work according to internal and external guidance’s, SOPs and respective timelines 

​Minimum Requirements:

• Good skills in presentation and scientific/technical writing  

• Good knowledge of relevant software tools (word and excel) 

• Good documentation skills and able to understand and exactly follow written procedures 

• Good knowledge on Module 3 

• Basic knowledge of regulatory guidelines 

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged! 

The future is ours to shape!

Skills Desired

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