Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Jobgether; Países Bajos; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Jobgether is seeking a Sr Regulatory CMC Consultant based in the Netherlands to lead regulatory CMC activities for small-molecule programs. You will apply regulatory expertise, ensure product lifecycle compliance, and collaborate with global teams in a fast-paced consulting environment.

This senior role focuses on interpreting North American regulatory requirements, maintaining marketed products, and contributing to reporting and surveillance.

Formación

• At least 8 years in pharmaceutical/biotech regulatory affairs or a related field.
• Strong knowledge of North American regulatory framework.
• Experience in regulatory activities for maintaining marketed products, including reporting and surveillance.
• Excellent written and verbal communication skills.

Responsabilidades

• Provide senior-level Regulatory CMC expertise for small-molecule products.
• Support compliance with North American regulatory requirements.
• Maintain regulatory oversight and lifecycle activities for marketed products.
• Interpret regulatory guidelines and translate into actionable recommendations.
• Collaborate with cross-functional teams to address regulatory questions.
• Plan, prioritize, and organize work to meet deadlines.
• Communicate findings clearly to technical and non-technical stakeholders.

Conocimientos

Regulatory affairs

Communication

Project management

Cross-functional collaboration

Drug development knowledge

Educación

Bachelor's/Master's/PhD in life sciences

Herramientas

Veeva RIM

Descripción del empleo

Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have based in Netherlands.

We are seeking an experienced Regulatory CMC Consultant to support regulatory affairs activities for small-molecule pharmaceutical products. In this senior consulting role, you will apply your expertise in regulatory requirements, drug development, and product lifecycle management to help ensure products remain compliant throughout their time on the market. You will assess regulatory guidelines, support ongoing regulatory obligations, and contribute to effective reporting and surveillance processes. Working in a collaborative, international life sciences environment, you will partner with cross-functional teams to address complex regulatory needs. This opportunity is suited to a knowledgeable professional who can combine strong technical judgment with clear communication and organized project execution.

Accountabilities

You will provide senior-level regulatory CMC expertise, supporting the maintenance and regulatory oversight of pharmaceutical products while ensuring activities align with applicable North American requirements.

• Support regulatory affairs activities for small-molecule pharmaceutical products, with a focus on Chemistry, Manufacturing, and Controls (CMC) requirements.
• Apply knowledge of the North American regulatory framework to support product compliance and lifecycle activities.
• Contribute to processes for maintaining products on the market, including regulatory reporting and ongoing surveillance.
• Interpret and assess relevant regulatory guidelines and requirements, translating them into practical recommendations.
• Apply an understanding of drug development principles and related regulatory concepts to assigned projects.
• Collaborate with internal teams and stakeholders to address regulatory questions and support project deliverables.
• Plan, prioritize, and organize work efficiently to meet project objectives and deadlines.
• Communicate regulatory information, findings, and recommendations clearly to technical and non-technical stakeholders.

Requirements

The ideal candidate combines extensive pharmaceutical or biotechnology industry experience with strong knowledge of regulatory affairs and the ability to work effectively in a consulting environment. Required qualifications include:

• Bachelor's, Master's, or PhD degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs, or another life sciences discipline.
• Typically, at least 8 years of experience in the pharmaceutical or biotechnology industry, regulatory affairs, or a related field, or an equivalent combination of education and experience.
• Strong knowledge of the North American regulatory affairs framework.
• Experience or sound understanding of regulatory requirements and processes for maintaining marketed products, including reporting and surveillance.
• Good understanding of drug development and associated regulatory concepts.
• Ability to interpret, evaluate, and apply regulatory guidelines.
• Excellent written and verbal communication skills.
• Strong organizational and time-management skills, with the ability to plan, prioritize, and contribute to multiple tasks and projects systematically.
• Ability to work collaboratively and contribute effectively within cross-functional teams.

Additional Preferred Expertise

• Hands-on experience with small-molecule CMC regulatory activities.
• Practical experience using Veeva RIM, which is specifically required for this opportunity.

Benefits

• Opportunities to collaborate with international experts across the biopharmaceutical industry.
• Access to professional development, career progression, and technical and therapeutic-area training.
• Supportive and engaged line management.
• Peer recognition and a comprehensive total rewards program.
• Exposure to emerging technologies, scientific knowledge, and complex regulatory challenges.
• Opportunities to explore different career paths within a growing global organization.