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Regulatory Operations Intern

3 months ago

Uxbridge, United Kingdom Regeneron Pharmaceuticals Full time

Primarily reporting into the RIM or Publishing teams but potentially getting to work across both groups and within the broader Reg Ops team (publishing, RIM and RSPM). This intern candidate would be supporting RIM/Publishing initiatives & exposure to key department projects and regular work, such as electronic regulatory dossier publishing, RIM training and change management activities and other data, systems or regulatory record requirements. There may also be an opportunity to work within the RSPM team to gain exposure to project management for regulatory submissions

JOB RESPONSIBILITIES:

  • Electronically format, publish electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.

  • Provides assistance with training and organizational change management activities.

  • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing or RIM standards and procedures.

  • Identifies and communicates regulatory system enhancement needs or technical issues.

  • Assists with regulatory record activities.

  • Collaborates with other RegOps teams on Regulatory Operations related tasks.

  • Provides support and backup to RegOps teams as needed.

JOB REQUIREMENTS:

Experience

  • knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc) would be beneficial.

  • Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.

  • Good organizational skills

  • Strong communication capabilities

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.