Job Summary

The scope of this position is to serve as the end-to-end execution of the product. The candidate is expected as standard to provide regulatory guidance, strategy and compliance expertise on all matters and manage CMC regulatory aspects for the product including the preparation of submissions and managing change control related to applications for regulatory agencies. Responsible for the maintenance of the US dossier of the assigned products. Responsible for change control US assessment for the assigned products. Takes care of the program and the execution of the RA lifecycle activities for the assigned products, in line with business targets.

What you'll do

• Manage the regulatory aspects of chemistry, manufacturing and controls for plasma products including the preparation of quality submissions in support of applications to FDA,
• Review manufacturing change controls for plasma products including assessing changes and regulatory impact to INDs/CTAs/BLAs and determining submission requirements.
• Works with project team to determine plans for developing change documentation required for submissions.
• Management of the planning, preparation, and submission of licensing applications (BLA/MAA).
• This role will be the FDA liaison contact for any discussions and regulatory meetings for end-to-end of the product.
• Thoroughly reviews the CMC dossier created by the global Regulatory team to ensure it meets US requirements.
• Lead the preparation of post-approval supplements (annual reports, supplement, and amendments) with focus of Chemistry, Manufacturing and Control (CMC) using eCTD format.
• Responsible for the maintenance of the US dossier of the assigned products.
• Responsible for change control US assessment for the assigned products.
• Takes care of the program and the execution of the RA lifecycle activities for the assigned products, in line with business targets in cooperation with GPOs.
• Support GPOs to prepare technical and administrative sections of US Dossiers. Plan and coordinate the preparation of the answers to the list of questions received from FDA for the assigned products
• Archive submissions via planning and tracking tools
• Maintain US licensed dossier baseline.
• Interface with functional areas to identify and obtain information required for regulatory submissions, with ability to summarize scientific data.
• Liaise with internal teams such as clinical, manufacturing, quality, operations and other.
• Develop and/or review regulatory documents to ensure all submissions are of high quality.
• Ensure alignment of regulatory strategy to business strategy across functional areas.
• Develop collaborative relationships to facilitate the accomplishment of work goals.
• Continually monitor newly published FDA guidelines and international guidance documents in the context of and ongoing development programs.
• Provide training on applicable requirements for scientific staff as required.
• Participates in regulatory agency inspections as needed, ensure contents of submissions are available, assist with responses, and coordinates with managing departments for inspection readiness.
• Instrumental in keeping all regulatory documents up to date for all applicable countries by appropriate annual or other updates, reports, etc.
• Participates in direction/supervision of vendors/contractors involved in providing the company with additional regulatory support, if needed.
• Other duties as required, and the role will collaborate with tasks across the existing US Regulatory Affairs team

Qualifications and need-to-know

• Advanced degree (MS, Ph.D., PharmD) in science or healthcare discipline is required.
• Professional certificate is preferred, i.e., RAC
• Minimum of 8 years of relevant pharmaceutical experience with minimum of 3-5 years in Regulatory Affairs/CMC for a biological product.
• Demonstrated expertise in US regulatory requirements; ability to interpret and apply regulations () to specific projects. Knowledge of global requirements is a plus.
• Extensive knowledge of regulations relevant to the area of expertise including FDA and ICH guidelines, as well as CTD requirements for biologics.
• Knowledge of change control requirements for manufacturing and testing of clinical and commercial products.
• Excellent operational skills including planning, organizing, time management and ability to motivate and lead others.
• Good negotiating and interpersonal skills, as well as the ability to communicate effectively.
• Balance time pressure with quality of submission that is acceptable by the FDA.
• Good analytical skills and ability to provide arguments or advice on complex situations.
• Language: fully fluency in oral and written communication in English
• Willingness/ability to travel domestically up to 10% of time, if needed. International travel may be required.