Director, Regulatory Affairs at IQVIA in Cambridge, MA

Job description

Details:

• 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.

Qualifications:

8+ years significant experience in regulatory affairs, or appropriate relevant experience.

Ph.D Pharmacy, Chemistry, Biology or Science Degree

• Requires scientific and regulatory knowledge pertinent to development aspects, particularly Chemistry, Manufacturing & Change (CMC)
• Operational knowledge of IND, NDA/BLA regulations and experience in US regulations pertinent to product development
• Experience in liaising with major regulatory Agencies, preferably FDA and Health Canada
• Ability to manage, mentor and train direct reports.
• Demonstrated knowledge in regulatory affairs and drug/vaccine development
• In depth understanding of the required documentation to be included in NDA/BLA submissions, annual reports, CBEs
• Evidence of proactive leadership to identify issues and maximize opportunities. Ability to quickly assimilate facts and data and develop an understanding of complex matters.
• Experience in the development and licensure of drugs/vaccines in the US, Europe, and other major markets, with a special emphasis on US.
• Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside IQVIA
• Ability to resolve problems through resourceful use of information and contacts
• Enterprise thinking - needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• Provide input to/manage regulatory activities in order to obtain US licensure for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations.
• Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling and/or procedural) of project/product specific documents submitted to FDA (e.g. BLA, sBLA, Q&A, scientific consultations, PSPs, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements.
• Provide support in compiling/writing US relevant sections of meeting requests, briefing documents, orphan drug designation, expedited review, etc.
• Provide US strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders.
• Cover project-specific responsibilities and serve as line reviewer for US submissions to ensure adequacy and optimization where possible of US/Canada specific aspects
• Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA and Health Canada.
• Evidence of proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Ability to manage individuals (including indirectly) 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 understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.

Preferred qualifications:

• 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.