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

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. Your responsibilities will include:

• 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.