CMC Regulatory Affairs Specialist

Job Responsibilities:

• Prepare, compile, and update CMC sections of IND (FDA) and IMPD (EU) submissions, including amendments, annual reports, and responses to questions from health authorities.

• Manage the day-to-day regulatory affairs activities for specific projects to achieve company and RA department objectives. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.

• Collaborate with the clinical team to ensure the investigational materials meet regulatory requirements for clinical studies intended for submissions.

• Assist and provide guidance on developing and maintaining CMC-related SOPs, including change control procedures and stability protocols, regulatory risk assessments for manufacturing, supply chain, and testing to ensure compliance with ICH guidelines and propose mitigation strategies.

• In charge of compiling and maintaining a regulatory-compliant Drug Development File.

• Maintain the electronic/paper regulatory archives for all projects, including health authority correspondence.

• Keep up to date with changes in regulatory legislation and guidelines.

• Review and supervise vigilance activities and documentation.

• Outline requirements for labeling and packaging.

Position Requirements:

• Relevant degree in life or medical sciences.

• Minimum 3 - 5 years of experience in CMC regulatory affairs from the pharmaceutical industry, preferably for drugs in the clinical development stage.

• Advanced knowledge of US drug regulation, CMC.

• Experience in combination drug-device products or previous professional experience In the medical devices industry - an advantage.

• US Drug for inhalation and Botanical drug - an advantage.

• Familiarity with European (preferably MDR) medical device regulation, and Canadian and US medical device regulations - an advantage.

• Ability to work independently with minimal direction or within project teams to attain group goals.

• Ability to creatively complete activities within aggressive time schedules.

• Excellent communication skills and ability to collaborate with team members and external stakeholders.

• Fluent in English and excellent writing skills.