Regulatory Affairs Specialist
Describe the primary purpose of this role as well as the Geographical scope (Global/Regional/Local) and any regulatory responsibilities
Prepare and deliver regulatory operational plans for assigned projects/products within a specific region. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
Describe the main accountabilities for this role including significant tasks, responsibilities and projects
Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
Lead the planning, preparation and delivery of both simple and complex submissions throughout the product s life cycle from either a global and/or regional perspective.
Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
Maintain awareness of competitors activities and share potential impact these activities may have on the product development program
Delivers project assignments supporting the business e.G. Representation on functional workstreams
Ensure that appropriate, up-to-date records are maintained for compliance
Assist in development of regulatory standards and SOPs
Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
Assist in due diligence activities for in-licensing opportunities
EDUCATION & QUALIFICATION
Bachelor' s Degree
List the type and length of experience
5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
Include specific skills, behaviors and knowledge necessary to meet the objectives of the role
Build effective partnerships identifies opportunities and takes actions to build effective relationships within team and with other areas
Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations.
Communication skills knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
Results focused ability to overcome obstacles and achieve key outcomes
Analytical logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
Integrity overriding commitment to integrity and high standards in self and other