Regulatory Affairs Consultant - Labelling

Labelling specific expectations:

• Previous experience working in industry in support of Global Labeling, Regulatory (Clinical / Safety), or Medical Writing for labelling updates

• Use of document management tools (internal systems) and external platforms

• Strong familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks

• Knowledge of the triggers that lead to a CCDS update, and ability to manage/coordinate impact assessments for technical changes impacting labelling

• Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling

• Familiarity with CCDS governance processes in Pharma Companies

• Some understanding of Periodic Safety Update Reports (PSUR) and potential impact on labelling

• Appreciation of the relationship between labelling and artwork processes

• Understanding of the regulatory processes required to update labelling of a product e.g different variation categories

• Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labelling variation.

• Some appreciation of the Regulatory requirements for labelling updates in different regions e.g. EU, EAEU, US and APAC.

• Knowledge of local labelling requirements .

• Review and approve promotion and advertising materials, medical education, and social media content in accordance with approved labelling and clinical materials. Participate in the promotion review committee and provide regulatory guidance in accordance with local market requirements.

Overarching project expectations:

• Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements

• Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear

• Completes activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction

• Facilitates client decision making by framing issues, presenting options and providing objective business advice

• Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities

• Acts as a trusted advisor to clients and/or project team on technical and/or process issues

• Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers

• Interacts professionally at multiple levels including senior management within a client organization

• Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems

• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management

• May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)

Requirements:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

• 8 years + experience in an industry-related environment, inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility from Australia including New Zealand.

• Client-focused approach to work

• Results orientation

• Teamwork and collaboration skills

• Consulting skills

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills