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.
- 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.
- 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.