Regulatory Affairs Manager III

The Fountain Group; Cambridge (MA); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager III to join their remote team. This exciting role involves leveraging your expertise in Regulatory CMC to develop and implement global regulatory strategies for pharmaceutical projects. You will be responsible for preparing and compiling submission documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams. If you have a strong background in the pharmaceutical industry and a passion for regulatory affairs, this position offers a fantastic opportunity to contribute to innovative projects while working from anywhere.

Qualifications

• 3+ years of experience in Regulatory CMC within the pharmaceutical sector.
• Bachelor's degree required, with strong knowledge of submission processes.

Responsibilities

• Lead and manage Regulatory CMC activities for assigned projects.
• Prepare and compile submission documentation for regulatory approvals.

Skills

Regulatory CMC expertise

Pharmaceutical industry experience

IND submission experience

Cross-functional team collaboration

Education

Bachelor's degree

Job description

The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows:

Job Description:

• Pay: 75.00-86.54/hr on W2.
• 6-month assignment to start with potential for extension or conversion.
• Qualifying candidates should have a bachelor’s degree, 3+ years total experience working in Pharma with at least 3 years of Regulatory CMC experience (manufacturing and testing).
• Experience delivering CMC content for IND or commercial submission activities.
• US or Latin American experience is a plus.
• This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned projects/products.
• Responsibilities include preparation and compilation of submission/documentation for specific projects working as or with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing routine and non-routine Health Authority interactions as delegated.
• Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early-stage development programs or working with the Regulatory CMC Lead for late-stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated.
• Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
• Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities).