Accenture is a global management consulting, technology services and outsourcing company, with more than 281,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world's most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$28.6 billion for the fiscal year ended Aug. 31, 2013. Its home page is www.accenture.com.
Accenture's Services workforce is a dedicated team of people who 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.
Regulatory Affairs Senior Associate
Workplace: Warszawa
Key responsibilities may include:
-
Provides support to the Regulatory Affairs project lead by assisting in the deliverance of project plans and regulatory strategy.
-
Supports the project team by assisting in the preparation of Regulatory Submissions, registration strategy and life cycle management. May also assist with filings and approval processes in the US, EU and/or Emerging Markets. Examples of regulatory submissions include but are not limited to license variations, renewals, annual reports, safety submissions, and protocol amendments. For such submissions, the Regulatory Affairs Senior Associate is expected to work independently and to ensure that all submissions adhere to regulatory requirements.
-
Actively seeks regulatory updates to maintain global regulatory intelligence databases.
-
Conduct regulatory reviews of technical and administrative documents for regulatory filings.
-
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.
- 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.
-
From 2-5 years of experience in pharmaceutical regulatory affairs, with experience in CTA submissions being an advantage. Additional experience in a Life Sciences industry may also be an advantage.
-
Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and/or local perspective. Candidates with experience in Clinical Trial Applications (CTAs) maybe be preferred.
-
Excellent international regulatory understanding and experience in handling business process excellence.
-
Ability to work within multidisciplinary project team across multiple geographic locations to build collaborative relationships with client and other experts in the regulatory field.
-
Establishes excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust.
-
Establishes confidence in one’s regulatory abilities and develops long-term trusting working relationships with project team and clients.
-
Promotes the professional growth of self to achieve individual and organizational goals.
-
Attention to detail.
-
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 (incl. you and your family members)
- 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