Senior Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements. The RAL acts as a liaison with internal and external clients and oversees the preparation and submission of regulatory documentation.

Essential Functions:

• Support the preparation of documentation and submissions under guidance.
• Coordinate and manage client deliverables ensuring regulatory compliance.
• Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.
• Exhibit good negotiation skills and the capability to work independently with direction, exercising independent judgment.
• Independently assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables.
• Possess basic knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
• Understand medical terminology, statistical concepts, and guidelines.
• Demonstrate good analytical, investigative, and problem-solving skills, with the ability to interpret data.

New Tasks and Responsibilities:

• Accountable and responsible for overseeing all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions.
• Manage country-specific local applications, overseeing the entire process from preparation to approval.
• Collect regulatory requirements and coordinate country-specific local applications, relying on RegView entries and follow-ups with CASs.
• Ensure adherence to standard RAL procedures applicable to EC and RA submissions.
• Oversee the development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs and Canadian ECs submissions
• Ensure that submission-related documents are received within the agreed timeline and filed according to agreed processes.
• Inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.
• Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel, both domestic and international.

Physical Requirements:

• Coordinate all North America IRB activities and ensure that essential document quality meets the expectations of Regulatory Compliance Review.
• Ensure timely North America regulatory and/or IRB submissions and follow up on all questions raised by ethics committees.

Management Role:

• No management responsibility.

This role requires a highly organized individual with strong regulatory expertise and the ability to manage multiple projects and adapt to changing priorities. The successful candidate will possess excellent communication and negotiation skills, along with a basic understanding of the regulatory landscape and procedures.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years).

Knowledge, Skills and Abilities:

• Good English language (written and oral) communication skills as well as local language where applicable
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Good negotiation skills
• Capable of working independently with direction and exercising independent judgment
• Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Basic understanding of medical terminology, statistical concepts, and guidelines
• Good analytical, investigative and problem-solving skills