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Job

US Senior Manager, Regulatory Affairs-Oncology

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2022-10-21

  • Startdate:

    ASAP

Senior Manager Regulatory Affairs-Oncology

If you feel like you’re part of something bigger, it’s because you are. Our clients shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

US Regulatory Affairs Sr Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will support one or more products from a regional regulatory perspective, achieve desired labeling by developing and executing regional regulatory strategies, and leading effective agency interactions.

  • To advise the GRT on regional considerations in developing strategy
  • To ensure the regional needs are well defined and implemented in collaboration with relevant regional partners
  • To ensure that our company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products in compliance with local laws and regulations and Company standards
  • To ensure regulatory compliance, with a focus on patient safety
  • Represent regional regulatory affairs as a member of the GRT, Evidence Generation Team (EGT), Clinical Study Team (CST), Label Working Group (LWG), and/or Regional Teams
  • Plans and handles regulatory submissions (e.g. clinical trial and marketing applications) for products within Company's portfolio in compliance with global filing plans and local regulatory requirements
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
  • Leads development of regional regulatory documents (including labels) and meetings in accordance with GRT strategy
  • Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations (eg, Breakthrough therapy), Fast Track, compassionate use and pediatric plan)
  • Advises the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
  • Manages regional label submission strategy and timelines, negotiation activities and deviation requests.
  • With minimal direction, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with GRT strategy, advise EGT on regulatory implications and requirements related to global clinical development plans and objectives
  • Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
  • Participate in LWG meetings with advice on local deviation requests
  • Communicate and ensure alignment of regional management before GRT strategy decisions
  • Partner with regional management and peers to ensure consistency in procedures and agency interactions

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a team-player with these qualifications.

Basic Qualifications:

  • Doctorate degree and 2 years of experience OR
  • Master’s degree and 6 years of experience OR
  • Bachelor’s degree and 8 years of experience OR
  • Associate’s degree and 10 years of experience Or
  • High school diploma / GED and 12 years of experience
  • Regulatory experience (relevant years as outlined above)

Preferred Qualifications:

  • MS Degree
  • Contemporary Oncology Regulatory experience
  • Regulatory knowledge in national regulations
  • Working with policies, procedures and SOP’s
  • Experience with national legislation and regulations relating to medicinal products
  • Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
  • Understanding of drug development
  • Negotiation skills
  • Good communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to anticipate and prevent potential issues
  • Communication of regulatory strategies such that expectations are understood
  • Anticipate regulatory agency responses to strategy
  • Strong understanding of and experience in regional regulatory environment in relevant product area and development stage
  • Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.
  • Regulatory submissions experience, experience interacting with regulatory agencies

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits