A dynamic start-up specializing in the design, development, and manufacturing of innovative medical devices for inhalation of Botanical drug substances.
Were looking for a CMC Regulatory affairs specialist to join our team and support the development and implementation of the companys regulatory effort.
As a Regulatory Affairs Specialist, you will be responsible for the approval and registration process of the companys products and will be in liaison with all relevant regulatory authorities worldwide.
Key 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.
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.
This position is open to all candidates.
