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.