Accenture is a global management consulting, technology services and outsourcing company, with more than 358,000 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$31.0 billion for the fiscal year ended Aug. 31, 2015. Its home page is www.accenture.com.
Accenture Accelerated R&D Services combines our capabilities across strategy, consulting, digital, technology and operations to simplify and accelerate the journey from early research to regulatory approval and throughout the product lifecycle. We leverage our deep industry experience and customer insights to improve business outcomes and help our clients bring life-saving medicines to market.
Regulatory Affairs Associate Director
Workplace: Warszawa
Nr Ref.: 00352488
Job Description:
- Provide strategic input into global regulatory plans for client taking into account commercial strategy, Health Authority (HA) regulations and guidelines, and issues or topics directly related to the project
- Maintain positive relationships with HA to facilitate and directly influence client interaction and support preparations and execution of successful meetings with HA
- Management of regulatory submissions, registration strategy and life cycle management and assistance with filings and approval processes in the US, EU and Emerging Markets
- Author, review and/or facilitate all types of documents that could be submitted to a HA to ensure submissions adhere to regulatory requirements
- Maintain global intelligence of product/project related HA regulations, submission guidance, recent approvals and precedents for client’s therapeutic area and/or assigned projects
- Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
- Maintain established regulatory reputation through work with clients, HA and trade associations
- Provide internal training, mentoring and supervisory support to Regulatory Affairs and Operations staff
- Ability to lead a multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, Health Authority and other experts in the regulatory field
- Establishes excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust
- Uses effective communication for one-on-one or small group conversations
- Promotes the professional growth of self and others to achieve individual and organizational goals.
- Expertise in preparing and submitting all forms of regulatory documents
- Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred
- Minimum 7 years of experience in pharmaceutical regulatory affairs, or equivalent industry experience
- Knowledge in handling registrations and maintenance of pharmaceuticals and/or biologics from a global & regional perspective and excellent international regulatory understanding
- Experience with a range of Clients and technology solutions which provides professional relevance
- Rich social benefit packages including: private medical care, Sodexo vouchers, Benefit sport club cards, life insurance
- Company car & petrol allowance
- 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
- 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."
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
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.Check out all our job vacancies at our website: www.pracaaccenture.pl
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"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."
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
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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