Regulatory Affairs Manager - CMC

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Regulatory Affairs Manager - CMC and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Regulatory Affairs Manager - CMC, you will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance, and expertise for product development from preclinical through registration and product optimization. You will act as liaison with internal and external clients in the provision and marketing of these services. You will also work with Regulatory Affairs Management to perform day to day operational aspects of the department such as preparing and assembling global regulatory submissions unassisted; interacting with sponsors; reviewing and assessing clinical trial regulatory documents; and reviewing and assessing scientific literature. Additionally, you will:

  • Review and provide technical advice to prepare regulatory submissions
  • Act as subject matter expert by providing regulatory strategy advice to internal and external clients
  • Provide project specific GRA strategy, technical expertise, and coordination oversight for key client projects
  • Ensure quality performance for key/managed projects
  • Manage project budgeting and forecasting functions
  • Identify and recognize out of scope activities in a contract in a timely manner and liaise with C&PD to follow through on all aspects of contract modifications
  • Assist business development in pricing and securing new business by making presentations to clients and developing proposal texts and budgets in collaboration with Proposal & Contracts Development
  • Deputize for functional manager in GRA as necessary
  • Provide guidance, training, coaching, and mentorship to other GRA personnel through liaison with the training manager
  • Provide staff with up-to-date legislation and guidance as it becomes available
  • Ensure compliance with relevant organizational and GRA SOPs and WPDs
  • Participate in launch meetings, review meetings and project team meetings

What You’ll Need to be Successful:

  • Bachelor's degree and at least 8 years of regulatory experience OR equivalent combination of education, training, and experience
  • Attention to detail and quality of documentation
  • Good interpersonal skills
  • Familiarity with Word, Excel, and PowerPoint
  • Effective oral and written communication skills
  • Excellent organizational and planning skills
  • Excellent negotiation skills
  • Ability to work independently
  • Proven ability to work effectively in a team environment
  • Expertise in global, regional, and national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management
  • Ability to handle multiple projects
  • Analytical and investigative skills
  • Ability to interpret data
  • Expert knowledge of ICH and other global regulatory guidelines
  • Expertise in preclinical, clinical, and/or CMC
  • Good judgement and decision-making skills
  • Ability to act as liaison with other departments
  • Knowledge of budgeting and forecasting

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Monday, March 15, 2021



Apply to this job
  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.