Associate Consultant, Regulatory Operations
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Job Description
Associate Consultant providing operational support in regulatory submissions for life sciences company. Role involves managing submissions and collaborating with cross-functional teams to ensure compliance and timely delivery.
Responsibilities:
- Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information
- Manage regional submissions and support global submissions
- Proactively communicates requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines
- Proactively collect necessary information from the Submission Team
- Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards
- Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools
- Analyze submissions and track and record life-cycle information in accordance with standards
- Perform complex searches on submission life-cycle information, as required
- Keep updated on regulatory authorities requirements on technical/format aspects of submissions worldwide and ensure their incorporation into RN standards
- Participate on special project teams (e.g., skill work, standards).
Requirements:
- Bachelor’s degree in Life Sciences, Business, or related field required
- 3-5 years of experience in management consulting, life sciences strategy roles, or a relevant field
- Strong analytical and problem-solving capabilities
- Rigorous attention to detail and accuracy
- Self-starter and driven
- Ability to multi-task with superior organization skills
- Strong ability to work independently as well as be an integral part of a team
- Dependable and flexible
- Excellent written, verbal communication, and time management skills
- Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio
- Ability to work in a global environment with an understanding of cultural differences and work practices
Benefits:
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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