Manager Regulatory Affairs

14 Apr, 2021

Jobs

Manager Regulatory Affairs

Medicago
Durham, NC

Let’s grow tomorrow, together!

Would you like to join a team of passionate people who will help you learn and actively participate in the company’s success like nowhere else?

Then read on and become part of our story!

 

How will you help change the landscape of technology and innovative products at Medicago?

 

Your role:

The incumbent is responsible for ensuring the coordination and management of clinical/nonclinical regulatory documents related to all pre and post marketing activities in all regulatory jurisdictions.

Your responsibilities:

  • Lead/plan/execute global regulatory clinical/non-clinical submissions, including timelines, for all assigned R&D and marketed products, collaborating with both internal and external stakeholders and/or staff to deliver against corporate timelines and broader corporate objectives in accordance with regulations and guidance;
  • Write and/or review technical clinical/nonclinical documents for global regulatory submissions, ensuring compliance and alignment with global regulatory requirements and strategy; Lead special projects in coordination with internal and external stakeholders;
  • Train and mentor regulatory staff and support other SMEs in regulatory requirements within designated functional areas;
  • Identify, review and implement Regulatory Affairs SOPs and RA processes;
  • Act as a point of contact for delegated Regulatory clinical/nonclinical subject matters or topics;
  • May represent the department internally on committees and intra-functional projects;
  • Responsible for implementing innovative initiatives in support of corporate objectives;
  • May provide analysis, trends and impact of surveillance of key Health Authority activities, including key approvals of competitor products, to the clinical/nonclinical landscape.

Minimum qualifications: 

  • PhD or M.Sc. in relevant field (biological or chemical sciences)
  • 10+ years, including experience as a Supervisor
  • Comprehensive knowledge of global regulatory agencies and regulatory submission processes and ability to find material and information
  • Demonstrated ability in completing larger Regulatory documents such as clinical/nonclinical M2 summaries and overviews and ensuring consistency between individual document content of a large submission
  • Demonstrated successful experience in Regulatory agency interactions and major submissions and approvals (e.g. INDs/CTAs, BLA/NDS/MAA)
  • Comprehensive understanding of GLP / GMP / GCP
  • Excellent oral and written communication skills
  • Demonstrated ability to defend difficult positions and sway opinion
  • Demonstrated ability to align teams, including regular cross-functional interactions with external vendors and other departments
  • Comprehensive knowledge of Office Suite

Medicago is changing the game!

 

Our Vision: A world better prepared to deal with any disease.

Our Mission: To create and deliver effective responses to new global health challenges.

Innovation, collaboration, integrity, adaptability, ownership and involvement of our colleagues are the keys to the success of our research. We have been cultivating the future together since 1999.

 

Medicago’s journey is a story of innovation and perseverance. Even the company’s name – the Latin name for alfalfa, the first plant we worked with – is a reminder of our culture of adaptability. We’re proud of our humble beginnings and our current growth and global reach.

 

As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.

 

Medicago promotes an open and inclusive work environment for all our employees.

 

It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.

Learn more here

Job posted: 2021-04-14