Manager, Combination Products, Regulatory Affairs at Regeneron

A Manager, Combination Products, Regulatory Affairs leads combination product regulatory activities, including device development activities, protocols reviews, HA correspondence and submission.

A typical day might include the following:

  • Providing regulatory interpretation, position and strategy for combination products and device requirements
  • Supporting device development activates from regulatory standpoint during early phase, development, submissions and post market requirements
  • Supporting development of design control documentation and quality systems for combination products
  • Supporting combination regulatory submissions, including collecting HA feedback, IND, CTA, BLA applications and MAA filings.
  • Conducting HA correspondence on combination product topic and lead HA meetings on this topic

This role might be for you if:

  • You have expertise with device regulations; and understanding of global regulatory requirements for device and combination products
  • You have regulatory submission experience
  • You have strong technical writing and oral communication skills
  • You are experienced with writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.
  • Experience with Health Authorities, V&V protocols and test reports is a plus
  • Previous experience with device regulatory requirement and development process for combination products is a plus
  • Experience preparing information for 51O(k:),BLA, IDE, IP and PMA submissions, especially as relates to human factors, is a plus

To be considered for this opportunity, you must have at minimum a Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar and 10+ years’ experience, Master’s Degree with 8+ or PhD with 3+ years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective. An ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment. This is a hybrid role requiring you to be onsite 2 times a week, with 3 days work from home.
#LI-Hybrid 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.
Salary Range (annually) $108,200.00 - $176,600.00

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