Role and Company Overview We are currently searching for a Regulatory Associate to join our Regulatory Affairs Operation team to help plan, manage, and submit regulatory submissions in the North America region (USA and Canada).
The role may also participate in the development and implementation of regulatory and operations strategy, operational tasks including document management and workflow processes, and creating/communicating submission timelines to key stakeholders.
Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50 countries, for patients with life-threatening conditions and chronic illnesses.
Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions.
Apollo Global Management is the private equity sponsor of Covis Pharma.
If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.
WHAT YOU CAN EXPECT TO DO IN THE ROLE: Reporting to the Director, Regulatory Affairs and Operations, Head of NA you assist with the management Veeva RIM Vault, including creation of submission records and importing submission documents.
You work with the regulatory affairs team to ensure all aspects of regulatory affairs are properly planned and formulated and executed according to FDA and other agency regulatory requirements.
You work with cross-functional teams to prepare submissions and submission timelines.
You assist with creation of Standard Operating Procedures to ensure activities are process driven and roles/responsibilities are clearly communicated.
You communicate status on a regular basis to direct management and regulatory leadership as requested.
You maintain clinicaltrials.gov records and assists with advertising and promotion, artwork/labeling updates, as needed.
FOR THIS ROLE YOU WILL NEED: A minimum of a BS in pharmaceutical, science or related field; MS or other advanced degree preferred, though the combination of experience and educational background of each candidate will be evaluated.
RAC certification a plus.
Previous RA experience with operational and technical expertise in eCTD and submission standards.
Previous experience with Veeva RIM or other electronic documentation management system a plus.
Project management experience and skills.
Self-starter mentality eager to learn new skills and improve processes.
Hands on approach and working to tight deadlines.
OUR OFFER TO YOU: By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development.
You will be able to provide input into impactful decisions and be a part of shaping our company’s future.
The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us.
We offer opportunities for advancement and support this through multiple development channels.
Our inclusive company culture brings unique perspectives and embraces diversity of thought.
We actively seek to hire and develop the best and brightest team members from all backgrounds ensuring our continued success into the future.
GET TO KNOW US: Find out more about Covis Pharma by visiting www.covispharma.com Find out more about Apollo Global Management by visiting www.apollo.com 06022021