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beign your career journey with accenture

Accenture
Accenture
location iconLocations: Warszawa
level iconLevel: specialist

Regulatory Affairs Sr. Associate / Sr. Submission Coordinator

This role requires the holder to demonstrate a moderate level of experience in regulatory affairs in at least one global region (e.g., Europe, US, Emerging markets). This position defines and produces all high-end publishing tasks and documentation associated with regulatory submissions. This position should have the capacity to grow into a publishing lead and become a role model for the members on the team.

With minimal supervision, the Regulatory Affairs Senior Associate supports preparation, validation, and review/QC of regulatory documents. This includes global and country-specific CMC/labelling documents and submission-ready components for major applications and lifecycle submissions. The role also reviews submissions to ensure eCTD standards per Health Authority regulations and guidelines are met, with focus on the technical metadata, submission content, and life-cycle management of the submission/application. Expectations for this role is that it requires enormous attention to detail, willingness to mentor, and initiative to be involved and a motivator for the team and the organization.

With minimal supervision, this role is expected to perform the following activities, depending on the project(s) assigned:

  • Assist in preparation, updating and review of labeling documents (CCDS/CCSI), and of country- specific labeling documents by using CCDS/CCSI.

  • Prepare & review CMC documents for original and lifecycle management submissions based on regulatory reviews of technical summaries, quality, nonclinical and clinical study reports, and administrative documents for regulatory filings.

  • Conduct regulatory QC reviews of Module 1 administrative regional documents for accuracy and completeness

  • Conduct regulatory QC of Module 2 summaries, Module 3 technical CMC documents, Module 4 preclinical reports and Module 5 Clinical Study Reports (CSRs).

  • Conduct review of complete IND, CTA application eCTD xml backbones for eCTD compliance and accuracy.

  • QC/Review IND, CTA documents to ensure they follow eCTD authoring granularity

  • Provide guidance and recommendations on content location within the eCTD structure.

  • Assure submissions adhere to EMA, FDA, ICH, other Health Authority Regulatory guidelines.

  • Compile routine investigational and marketed products global maintenance submissions.

  • Assist with the filing and approval processes for investigational and marketed products.

  • Assure submission process and standards adhere to Accenture SOPs.

  • Document-level quality control.

  • Populate document information fields.

  • Creation of item-level TOCs.

  • Be prepared to deploy on-site to support eSUB projects.

  • Demonstrate the ability to walk a client through the overall publishing process and an explanation of the publishing tools and tasks used to produce electronic submissions.

  • Willing to take on a leadership role within group.

What we expect from you is:

  • Bachelor’s degree (or equivalent, per geography) and 3+ years related industry experience

  • Proficiency in performing document reviews and quality assurance checks.

  • Good basic understanding of submission compilation and application requirements, and applicable regulations

  • Proficiency with publishing tools and computer applications.

  • A general knowledge of the drug development life cycle and the high-level content of a submission.

  • Oral and written capabilities to be reflected in client issue reports

  • Knowledge of EMA or FDA or other region HA /ICH Guidelines.

ABOUT US:
Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries — powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. With 509,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises. Visit us at www.accenture.pl

Accenture Operations provides business process services for specific functions, including finance and accounting; procurement and supply chain; and marketing & sales. We operate business processes with a combination of talent and data, artificial intelligence, analytics and digital technologies, helping clients to improve their productivity, customer experience and performance.

If you are interested, please send your CV in English by clicking "apply now!" button
When applying please enclose the below statement:

"I hereby consent to the processing of my personal data by Accenture Sp. z o.o. with its registered seat in Warsaw (00-121), at ul. Sienna 39, NIP 526-00-15-900 (Data Controller), in accordance with the Act of August 29, 1997 on the Protection of Personal Data (Journal of Laws of 2016, item 922) and the Regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive), necessary to carry out the recruitment process by Accenture. At the same time, I declare that I provide my personal data completely voluntary. I also declare that I have been informed about my right to withdraw my consent or object to processing of data, request access to them, rectification, deletion, limitation of processing and their transfer, at any time and the right to lodge a complaint to the data protection supervisory authority."

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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