Join
Verisfield as a Regulatory Affairs CMC Lead.
Are you
ready to elevate your Regulatory Affairs expertise? Verisfield, a dynamic and
innovative pharmaceutical company, is searching for a passionate Regulatory
Affairs CMC Lead to join our team and contribute to our mission of taking
treatment one step forward.
About Us
At
Verisfield, we take pride in our global footprint, reaching over 50 countries.
With a comprehensive portfolio of 160+ developments, we specialise in generics,
hybrid generics, and value-added medicines. By reformulating, combining, and
reinventing existing molecules, we deliver innovative solutions that enhance
efficacy, safety, and patient convenience.
We believe
in differentiation through innovation and are driven by our commitment to
continuous evolution.
The Role
As the
Regulatory Affairs CMC Lead, you will work closely with our Regulatory Affairs
Officers and report to the Regulatory Affairs CMC Manager. In this pivotal
role, you’ll ensure compliance with current pharmaceutical quality
requirements, lead the preparation, evaluation, and management of technical
dossiers and regulatory submissions, while providing guidance to junior team
members.
Key Responsibilities
- Review, compile, and coordinate
technical dossiers (Modules 2.3, 3) for new pharmaceutical product
developments
- Conduct gap analyses on
existing technical dossiers to ensure alignment with evolving regulatory
requirements
- Oversee regulatory compliance
for marketing authorisations and coordinate quality-related changes
- Prepare responses to competent
authorities and evaluate active substance manufacturer master files
- Mentor and train junior
Regulatory Affairs personnel, equipping them with the skills and knowledge
to excel in CMC practices
- Stay informed about current
legislative requirements to maintain regulatory excellence
- Analyse quality variations and
ensure documentation is archived per SOPs
- Maintain and update department
databases
Qualifications
- University degree in Pharmacy,
Chemistry, Biology, or a related field
- At least 6 years of experience
in CMC Regulatory Affairs
- Strong understanding of Quality
Requirements in Pharmaceutical Legislation
- Excellent command of the
English language and strong computer literacy
What We Offer
- Competitive compensation and
benefits package, including health insurance
- Opportunities for continuous
professional development and career growth
- A collaborative and supportive
work environment
- Chance to contribute to
innovative pharmaceutical products development
At
Verisfield, we believe in striving to never settle, always evolve. If you’re
ready to embark on this exciting journey and be part of a forward-thinking
company, apply now!