Consultant CMC Regulatory Affairs

Compliance Services - Frankfurt

About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

About us

Open Position

Mission

Tasks and responsibilities

Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their pharmaceutical products to market
Advise clients on the CMC data and information necessary to support dossier approval
Perform gap analysis on existing dossiers for regulatory approval
Prepare, review, and submit high-quality regulatory documents and submissions in close collaboration with client CMC functions, mainly to EU and US health authorities, including IMPD and IND
Support clients in the liaison with health authorities, facilitating effective communication and swift resolution of issues, including responding to deficiency letters
Keep abreast of changes in global regulatory guidelines, standards, and policies, interpreting their implications for client projects
Provide training to clients' internal teams on global regulations, guidelines, and processes
Support in business development on regulatory affairs services

Studies

Your profile

Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field
Minimum of 5 years' experience in CMC Regulatory Affairs within the pharmaceutical industries
In-depth knowledge and understanding of EU and US CMC regulations and submission processes
Demonstrated success in preparing and managing EU and US submissions and approvals
Proficiency in project management and ability to handle multiple projects simultaneously
Good understanding of Good Manufacturing Practices (GMP)
High degree of quality awareness
Ability to demonstrate professional knowledge within RA and Health Authorities
Excellent English and German written and verbal communication skills
Ability to work in international and interdisciplinary teams
Strong attention to detail, self-contained, and responsible way of working
Willingness to continuously improve and to grow with new challenges
Willingness to travel, including overseas