Regulatory Affairs CMC Manager

Job content

This role will be based in either our Zug, Switzerland or Amsterdam, Netherlands site. You must have local or EU work authorization in order to be considered for the role.

Role and Company Overview

We are currently searching for a Regulatory Affairs CMC Manager to work with other RA CMC team members and be a member of multifunctional teams (company internal team members and third party CMO’s) to provide executional support for the needs of the Company from a regulatory point of view to ensure successful applications with health agencies in the most efficient way.

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 Senior Director, Project Management you represent the Regulatory Affairs (RA) team as CMC expert on project teams and contribute to RA CMC strategies for CMC related projects (product development, technology transfers, etc.). You are responsible for the timely completion of well organized, scientifically sound regulatory CMC submissions, to include agency meeting packages, DMFs, INDs, CTXs, NDAs and MAAs, amendments and supplements, responses to requests for information, etc. Writing of Module 3 sections/participation in submission preparation is expected. You maintain an in-depth level of understanding of the assigned compounds, their characteristics, manufacturing aspects and specifications/analytical methods. You review technical reports and summary documents (chemistry, manufacturing and quality) for adherence to regulatory guidelines, strategies, and commitments. You contribute to writing expert summaries of CMC submissions. You perform RA Change Control review and co-ordinate with QA to ensure successful implementation. You assist with preparation for CMC meetings with Health Authorities. You maintain an understanding and awareness of existing and forthcoming legislation and guidelines related to CMC. Lastly, you provide regulatory expertise and policy support for GMP.

FOR THIS ROLE YOU WILL NEED:

· A minimum of a BS in pharmacy, chemistry, related field or equivalent.

· Minimum 5 years’ experience in the pharmaceutical industry in a CMC function in either a technical or regulatory affairs role with experience of authoring/review of module 3.

· Previously worked in a cross functional team and with third parties.

· Experience in implementing RA CMC strategies.

· Sound knowledge of FDA/ EMA regulations and guidelines in the CMC arena, including GMP. Knowledge of requirements in other regions is of advantage.

· Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation, and drug product technologies.

· Outstanding planning, communication, collaboration and influencing skills.

· Ability to write and edit technical documents.

· Outstanding planning, communication, collaboration and influencing skills.

· Fluency in the English language both written and oral.

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