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Regulatory Affairs Associate/Specjalista ds. Rejestracji Leków

Job Location: Warsaw

Job Number: 00444717

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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 more than 375,000 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.



Key responsibilities may include

 

  • Provides input into multiple Regulatory projects inclusive of EMA Policy 0070 clinical data redaction engagements.
  • Authors, compiles and or reviews various Regulatory documents.
  • Authors or reviews Accenture RA SOPs, internal guidance documents and training materials.
  • Liaises with internal and external teams to meet project deliverables.
  • Coordinates project timelines and workflows.
  • Supports Regulatory Operations in the generation and assembly of all types of Global electronic submission filings including eCTD and NeeS.
  • Maintains and updates metrics in appropriate databases.
  • Archives all client data and documents in appropriate databases per appropriate Accenture or client SOPs.
  • Assure standards adhere to Accenture and/or client SOPs and guidance.

  • Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred.
  • Excellent written and verbal communication skills in English.
  • Up to 2 years’ experience in pharmaceutical regulatory affairs. Additional relevant experience in a Life Sciences industry may be preferred.
  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
  • Excellent international regulatory understanding and experience in handling business process excellence.
  • Establishes excellent working relationships with peers and team members through integrity, credibility, reliability and trust.
  • Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships.
  • Promotes the professional growth of self to achieve individual and organizational goals.
  • Attention to detail.
  • Analytical/strategic skills
  • Ability to work on numerous projects and under pressure. 


We offer
 
  • Opportunity to work for the most recognized brands in the world
  • Attractive salary
  • Online and classroom trainings
  • Notable discount for the language courses
  • Social benefit packages including: private medical care, Sodexo vouchers, Benefit sport club cards, life insurance, professional foto classes
  • Open communication among all employees and across the teams
  • Ongoing mentoring and support not only during the induction period
  • Friendly work atmosphere and chill-out spaces for chats
  • Accelerate runners club and the participation in various employee initiatives
  • Beverages (as coffee, tea) at any time you want 

 

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."

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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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