Regulatory Affairs Associate - Rest of World (ROW)

Job content

Role and Company Overview

We are currently searching for an Associate, ROW Regulatory Affairswho will be dedicated and motived to work within the regulatory affairs team and will be responsible for implementing regulatory activities for assigned projects.

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.

Reporting to the Head of ROW Regulatory Affairs the Associate, ROW Regulatory Affairs will interact with all departments and actively build the future of the company.

WHAT YOU CAN EXPECT TO DO IN THE ROLE:

• Coordinate, prepare or review regulatory submissions for all projects to include but not limited to new MAAs, variations and other associated life cycle maintenances submissions.
• Support and facilitate all life cycle maintenance activities with partner CROs & different third-party pharmaceutical companies and internal departments
• Support assessment of change controls for the regulatory team
• Help with regulatory related questions and complaints
• Oversight of the artwork approval process of new packs or changes to existing packaging
• Coordinate the labelling (SPC, PIL and Labelling) for compliance against current local guidelines and standards in collaboration with the party companies
• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved effectively and on time
• Maintain relationships with the third-party pharmaceutical companies
• Have oversight on current knowledge base of existing and emerging regulations, standards or guidance documents
• Follow company policies and procedures
• Collaborate with team to establish and meet targets and timelines
• Help generate SOPs and Work instructions

FOR THIS ROLE YOU WILL NEED:

• University degree in life science, pharmacy, pharmacology, medicine or related discipline and possible higher degree
• At least 3 years Regulatory Affairs experience
• Experience in filing new registrations globally (ROW)
• Experience in implementation of variations and life cycle management globally (ROW)
• Literate in Microsoft Office applications
• Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
• Very good collaboration, communication, and negotiation skills
• Fluency in the English language mandatory, German and any other language is an advantage
• Intercultural working experience specifically with Asia preferred

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.

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

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