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Regulatory Affairs Senior Associate

Job Location: Warsaw

Regional Description: Poland

Job Number: 00590037

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- Job description

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions—underpinned by the world’s largest delivery network—Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 373,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

Accenture Operations is one of Accenture key capabilities dedicated to work on outsourcing engagements. These are long-term partnerships with clients for whom we manage and provide increasingly specialized business operations, such as finance and accounting, IT, applications development and maintenance, helpdesk services, and HR. We not only maintain key business functions for clients, we constantly seek to improve them to help our clients move ahead of the competition.


Accenture’s Accelerated R&D Services bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance (PV) functions around the globe. Our solutions, supported by outsourced operational activities and facilitated by customizable technology and infrastructure, allow pharmaceutical companies to bring drugs to market faster, at a reduced cost and with reduced  execution risks.


Your future is waiting – just make a step forward!

Would you love to work with passionate people from all over the world?

Are you dreaming about using your foreign language skills and at the same time gaining knowledge?

Take a just one look and decide if Accenture is a place for You!



Accenture’s Accelerated R&D Services (ARDS) bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance functions around the globe. 


You will:

  • Author and/or facilitate regulatory CMC and/or labelling documents for Health Authority submissions using Accenture or client agreed templates. 
  • Provide support to the Regulatory Affairs Project Manager by assisting in the deliverance of project plans and regulatory strategy.
  • Collate documentation for lifecycle maintenance of marketed products, e.g., new territory extensions, variations, renewals; ensuring that all submissions adhere to regulatory requirements.
  • Coordinate and maintain accurate regulatory information management of submission filing and approval in local markets.
  • Compile submission packages in document management systems and initiate the required publishing activities.

  • Minimum 4 years’ experience in a life sciences industry with a minimum 2 years of experience in pharmaceutical regulatory affairs in CMC or labelling.
  • Understanding of different CMC or labelling document requirements for global markets. 
  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
  • Knowledge of ICH Quality guidelines and Quality CTD content requirements.
  • Ability to coordinate with cross-functional teams and manufacturing sites to obtain supportive documentation in a timely manner.

We offer

  • The ability to use your knowledge of foreign language on a daily basis at work (we serve our Clients in almost 30 foreign languages)
  • Experience with a range of Clients and technology solutions which provides professional relevance
  • Operating according to Lean Six Sigma philosophy
  • Collaborating and learning from diverse and talented colleagues helps you “raise your game”
  • Trainings and development tailored to help you achieve your potential
  • New Joiners Programme including trainings
  • Opportunity  to engage in Corporate Social Responsibility initiatives
  • We also think about your social life, at Accenture you will be able to take part in different initiatives like Book Club, International Cuisine Club, Accenture Runners Club, family events, cultural meetings, photography classes, climbing, soccer, swimming and many others.
  • Social benefit packages including: private medical care, Sodexo vouchers, Benefit sport club cards, life insurance
  • Friendly work atmosphere in multicultural environment


When applying please enclose the below statement:

"I hereby express my consent to process my personal data included in my job offer by Accenture Sp. z o.o. or any other entity of the Accenture group for recruitment purposes and once the recruitment process is closed, I agree that Accenture Sp. z o.o. with its registered seat in Warsaw, 00-121, ul. Sienna 39 or any other entity of Accenture group places and processes my personal data in its database. I also express my consent to sending my personal data to third parties within the Accenture group pursuant to the Personal Data Protection Act of 29th August 1997 (Journal of Laws of 2002, No. 101, position 926 as amended). I submit the data voluntarily. I have been informed about the right of access to the content of my data and about the possibility of correcting them."

Check out all our job vacancies at our website:
www.accenture.pl/operationswarsaw

Accenture does not discriminate employment candidates on the basis of race, religion, color, sex, age, disability, national origin, political beliefs, trade union membership, ethnicity, denomination, sexual orientation or any other basis impermissible under Polish law.”

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