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.
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.
- Provides support to senior Regulatory Affairs staff by assisting in the completion of regulatory tasks.
- The Regulatory affairs associate works on multiple types of regulatory documents under the direction of more Senior Regulatory Affairs staff.
- Maintains and updates metrics in appropriate databases.
- Archives all client data and documents in appropriate databases per appropriate Accenture or client SOPs.
- Support Regulatory Operations in the generation and assembly of all types of Global electronic submission filings including eCTD and NeeS under the direction of more Senior Regulatory Affairs staff.
- Performs final regulatory affairs review of documents.
- Assure standards adhere to Accenture and/or client SOPs and guidance.
Qualification
- Master’s degree in natural science, life sciences or pharmacy.
- Excellent written and verbal communication skills in English.
- 2 years relevant industry experience (life science – clinical/analytical/manufacturing). Relevant experience in pharmaceutical regulatory affairs 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 is beneficial.
- Excellent international regulatory understanding and experience in handling business process excellence is preferred.
- 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.
- 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, My Benefit, life insurance
- Friendly work atmosphere in multicultural environment
