$200K — $250K *
• Manage a team of Regulatory Affairs professionals.
• Provide support for key regulatory activities pertaining to a project/product.
• Interact with internal project related teams for all parts of RA aspects of a given project on clinical RA strategy or procedural aspects.
• Participate in project/product-related discussions and provide strategic, scientific and RA input, for all parts of RA aspects of given project on clinical or procedural aspects.
• Provide input into the asset specific regulatory strategy on a global scale.
• Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities
• For cross-product sections or stand-alone documents work with the functional regulatory groups to ensure content is aligned with targeted overall profile of the product.
• Responsible for the delivery of high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical and procedural and accountable for one or several of the RA aspects.
• Act as the point of contact for Regulatory Agencies for assets ; Plan and lead activities associated with FDA meetings pertaining to a project/product
• Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
• Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
8+ years significant experience in regulatory affairs, or appropriate relevant experience.
Ph.D Pharmacy, Chemistry, Biology or Science Degree
• Experience in providing strategic advice on integrated regulatory development plans with a focus on CMC, and problem solving in cross-functional teams in drug/vaccine development
• Ability to coordinate and execute regulatory strategy for a given project/product.
• Ability to assess and determine regulatory strategy for development and life cycle management programs.
• Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
• Ability to identify and escalate issues to and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Proven influencing skills.
• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
• Ability to resolve problems through resourceful use of information and contacts.
• Enterprise thinking - needs to assess the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• Quality mindset
• Fluent in English, with excellent writing skills.
• Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
• In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
Valid through: 4/19/2021
$80K — $100K