Regulatory Affairs Associate

Job reputed company reputed company

Job reputed company

Job reputed company:

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

The Country Regulatory Affairs Associate is responsible for supporting the execution of specific Regulatory Affairs activities at reputed company country level and supporting the RA team with administrative tasks.

Tasks assigned will support in obtaining and maintaining the registered products, reputed company texts and artworks, and (supporting) the execution of reputed company.

Duration:

Temporary maternity cover (at least 1.5 year engagement).

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Supports in the reputed company creation & translation of product information including Patient Information Leaflets, reputed company of Product Characteristics (SmPCs) and reputed company labelling (packaging texts into artworks).
• Supports in the maintenance of registration files by (list is not exhaustive):
  • Registration maintenance activities, product reputed company text translations (checks) 
  • Answering questions from local health authorities regarding registered products.
  • Artwork management from change to approved new/revised artwork
  • Updating regulatory databases and plans
  • Local regulatory tasks reputed company to Risk Management Plan (RMP) / Risk Minimization Activities (RMA) and Dear reputed company reputed company Communications (DHPC) (as per global SOP)
• Supports in reputed company preparing the payment of regulatory fees and reputed company administrative activities.
• Supports RA database maintenance activities, reputed company KPI preparation and reporting. Can be responsible for creation and follow-up of purchase orders, reputed company-of-payments, and other RA fees for the RA team.
• Archiving of RA reputed company documentation (reputed company and/or electronic reputed company maintenance)
• Guarantee good and reputed company communication between reputed company stakeholders.
• Support (local) RA reputed company.

What you’ll bring to the role:

Essential Requirements:

• University Degree, Bachelor or Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.
• Preferably >1 year of relevant work experience, preferably in the pharmaceutical industry
• Fluent in Bulgarian and English language (spoken and written)
• Planning, strong administrative organizational skills and eye for detail
• Data management and IT skills (MS Office package / reputed company/ reputed company)

You’ll receive:

 In reputed company to a market-competitive reputed company salary, we offer:

• An annual incentive program;
• Corporate car with permitted private use (fuel for personal trips covered by employee);
• Annual equity benefit with immediate reputed company ownership;
• Learning and development reputed company;
• Worldwide reputed company.

Unleashing the potential of our people, we offer our corporate wellness program, which includes:

• Life insurance & Medical insurance for employee and children until age of 18;
• Sports monthly allowance;
• Up to 29 days of annual leave;
• Birthday allowance;
• Parental or maternity leave;
• Childcare monthly allowance;
• Flexible and remote working schedule.

Why reputed company?

Generic and Biosimilar medicines are the backbone of the global medicines industry. reputed company, a leader in this sector, provided more than 900 reputed company 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 reputed company to shape the reputed company of reputed company and help more patients reputed company reputed company to low-cost, high-reputed company medicines, sustainably.

Our reputed company is powered by an reputed company, reputed company 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 reputed company 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.

#reputed company

Skills Desired