Regulatory Affairs Specialist

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!

 

Job Description

For our Regulatory Affairs team, we are looking for a new Regulatory Affairs Specialist, based in Bucharest, who:

• Manages medium to small level global regulatory submission projects.

• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.

• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.

• Performs AW preparations and National texts translations

• Frequent internal company and external contacts.

• Represents organization on specific projects

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Key performance indicators:

- Adherence to Sandoz policy and guidelines

- Project & stakeholder feedback​

What you’ll bring to the role:

Essential Requirements:

Work Experience:

• Minimum 3-4 years experience in a Pharma company in a Regulatory Affairs position

• Functional Breadth.

• Collaborating across boundaries.

• Operations Management and Execution.

• Project Management.

Skills:

• Communication skills

• Data Analysis.

• Documentation Management.

• Lifesciences.

• Operational Excellence.

• Regulatory Compliance.

Languages :

• English - advanced level

You’ll receive:

Beside your well positioned salary in the market and your specific working tools (company car, laptop, Ipad, mobile):

·       Various benefits for holiday, Christmas, Easter and other occasions

·       Dental & ophthalmological benefits

·       Monthly sport benefit

·       Extra vacation days

·       Medical & life insurance

·       Meal tickets

·       Learning opportunities

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!

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.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:  Sandoz Talentpool (novartis.com)

#Sandoz

 

Skills Desired

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