RA Specialist, Publishing

Job Description Summary

Join us, the future is ours to shape!

Job Description

The Operations Publishing team is responsible for the delivery of published output which fulfils the technical and format requirements of the Health Authorities and is dispatched and / or submitted to the authorities according to given timelines and in high quality. of regulatory application cluster in terms of first level issue, change and user management.

The RA Specialist's overall purpose is to:

Ensure preparation, validation, dispatch and submission of compliant and high quality initial, 2nd wave and maintenance Regulatory filings according to submission plans.

Update respective Regulatory systems for Registration Management, Publishing and Document Management.

Support the Global Regulatory teams during the product development phase and provide input as appropriate

Follow Regulatory procedures and timelines

Your Key Responsibilities:

Your responsibilities include, but not limited to:

Support regulatory teams during the submission process in all administrative and technical steps according to global procedures

Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements

Ensure eCTD lifecycle maintenance according to ICH and regional specifications

Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant

Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates

Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents

Ensure escalation procedures are followed in case of issues and delays

Assist with document preparation activities such as scanning, bookmarking, hyperlink creation, and quality checks to ensure submission readiness

Support large-scale document upload and management activities

What you’ll bring to the role:

Essential Requirements:

University or College Degree in any field or life science with relevant industry experience or comparable degree

Good communication in English (oral and written)

Ideally experience in the area of Pharmaceutical and Regulatory Affairs.

Quality and compliance conscious

Participating and supporting as necessary in audits/inspections

Ability to quickly familiarize with new IT tools.

Good expertise in organization and prioritization of tasks.

Ability to communicate and operate effectively in an international and cross-functional environment.

Problem solution oriented

Team spirit and embracing diversity of cultures and personalities.

Ability to work independently, under pressure, demonstrating initiative and flexibility

You’ll receive:

We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people 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 careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Documentation Management, Operational Excellence, Regulatory Compliance