Sr. Regulatory CMC Specialist – Small Molecule & Veeva RIM

Jobgether; Portugal; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

International collaboration

Professional development and training

Structured career progression

Total rewards program

Exposure to emerging technologies

Global team exposure

Job summary

Jobgether is partnering with a client in Portugal to hire a Sr Regulatory CMC Consultant focused on small-molecule products. The role requires deep regulatory affairs expertise, particularly in CMC, and experience with Veeva RIM in a consulting environment.

You will support regulatory oversight for marketed products, ensure North American regulatory alignment, and contribute to reporting and surveillance activities within a collaborative, international life sciences setting.

Qualifications

• Bachelor's, Master's, or PhD in Biology, Chemistry, Pharmacy, Regulatory Affairs, or life sciences discipline.
• Typically, at least 8 years of experience in pharma/biotech or related field.
• Strong knowledge of the North American regulatory affairs framework.
• Experience with maintaining marketed products, including reporting and surveillance.
• Understanding of drug development and related regulatory concepts.
• Ability to interpret, evaluate, and apply regulatory guidelines.
• Excellent written and verbal communication skills.
• Strong organizational and time-management abilities.
• Ability to work collaboratively in cross-functional teams.

Responsibilities

• Support regulatory affairs activities for small-molecule CMC requirements.
• Apply knowledge of the North American regulatory framework to product compliance and lifecycle activities.
• Contribute to regulatory reporting and ongoing surveillance processes.
• Interpret and apply relevant regulatory guidelines to projects.
• Apply drug development knowledge to assigned projects.
• Collaborate with internal teams to address regulatory questions and deliverables.
• Plan, prioritize, and organize work to meet objectives and deadlines.
• Communicate regulatory information and recommendations to stakeholders.

Skills

Regulatory affairs knowledge

Written and verbal communication

Organizational and time management

Cross-functional collaboration

Regulatory guidelines interpretation

Drug development understanding

Project management

Education

Bachelor's/Master's/PhD in Life Sciences

Tools

Veeva RIM

Job description

Jobgether is partnering with a client in Portugal to hire a Sr Regulatory CMC Consultant focused on small-molecule products. The role requires deep regulatory affairs expertise, particularly in CMC, and experience with Veeva RIM in a consulting environment.

You will support regulatory oversight for marketed products, ensure North American regulatory alignment, and contribute to reporting and surveillance activities within a collaborative, international life sciences setting.