Regulatory Affairs Manager

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:

• Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects. Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings

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 9+ 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
• Capable of interpreting data