Join Verisfield as a Regulatory Affairs Senior Officer (CMC)
Are you
ready to take the next step in your Regulatory Affairs career? Verisfield, a
dynamic and innovative pharmaceutical company, is looking for a Regulatory Affairs Senior Officer (CMC) to join our growing team. This is your
opportunity to make a real impact in the development of high-quality
pharmaceutical products that improve lives worldwide.
About Us
At
Verisfield, we take pride in our global reach, with a presence in over 50
countries and a portfolio of 160+ developments. We specialise in generics,
hybrid generics, and value-added medicines, transforming existing molecules
into innovative solutions that enhance efficacy, safety, and patient
convenience. Innovation drives us, and continuous evolution defines us.
The Role
As a
Regulatory Affairs Senior Officer (CMC), you will serve as a key technical
contributor within the Regulatory Affairs team. Working closely with the
Regulatory Affairs Manager and mentoring junior Officers, you will support the
preparation, review, and management of regulatory submissions. Your in-depth
knowledge of CMC requirements and proactive approach will help ensure the
success of our pharmaceutical development projects across multiple markets.
Key Responsibilities
- Prepare, review, and coordinate
CMC sections (Modules 2.3 and 3) of technical dossiers for new product
submissions
- Evaluate existing dossiers to
ensure compliance with the latest EU and international regulatory
guidelines
- Lead the preparation of quality
variations and responses to regulatory authorities
- Liaise with internal
stakeholders, contract manufacturers, and suppliers to gather and verify
required documentation
- Perform gap analyses and
propose strategies to address deficiencies
- Provide guidance and technical
support to junior Regulatory Affairs Officers
- Contribute to the development
of departmental SOPs and maintain up-to-date regulatory databases
- Stay current with global
regulatory changes relevant to pharmaceutical quality and CMC submissions
Candidate Profile
- University degree in Pharmacy,
Chemistry, Biology, or a related field
- Minimum of 4 years of
experience in Regulatory Affairs with a focus on CMC; 6 years or more is
desirable
- Professional experience in the
Pharmaceutical Industry, in R&D, QC, or other related areas with
strong CMC exposure will also be considered
- Solid understanding of
pharmaceutical quality standards and regulatory requirements
- Strong attention to detail,
organizational, and analytical skills
- Excellent command of the
English language and strong computer literacy
- Experience mentoring or guiding
junior colleagues is a plus
What We Offer
- Competitive compensation and
benefits package, including health insurance
- Clear opportunities for career
advancement and professional growth
- A collaborative and
forward-thinking work culture
- The chance to be part of a team
that brings innovative medicines to patients globally
At
Verisfield, we never settle—we evolve. If you're ready to take the next step in
your Regulatory Affairs journey, apply today and grow with us.