Senior Manager, Global Regulatory CTA Therapeutic Area Lead

The Global Regulatory CTA Therapeutic Area Lead is a recognized SME in CTA and is responsible for the global management of Clinical Trial Authorizations (CTAs) with the view to obtain CTA approvals in the fastest and most efficient way while ensuring quality documentation. The Senior GRSL develops the CTA submission strategy of large and/or complex projects, provides regulatory project management of CTAs and oversees the CTA submissions.

This role is responsible for developing, maintaining and improving processes, drive development and improvement of new systems, solutions and procedures related to CTA activities and ensure compliance with international regulatory requirements and internal CTA procedures.

The Senior GRSL supports Global Regulatory Affairs (GRA) vision of excellence regarding CTA activities for assigned projects through strategy, good scientific practice, integrity and consistent compliance with local regulatory standards.

Interface with GRA TA leads and Clinical Development Operations Clinical Program Managers, Global Clinical Operations TA Leads to manage assigned product/projects and resolve cross-functional issues.

Coaches and trains lower level professionals through sharing of lessons learned, staying ahead of new CTA and regulatory trends and participate to opinion sharing as CTA experts in trade association in collaboration with the Global Regulatory Intelligence and Policy (GRIP) team.

Responsibilities and accountabilities:

• Lead CTA activities for large and/or complex clinical trials during the entire study lifecycle: develop overall CTA concept and provide CTA strategic inputs during GRA TA meetings, SET meetings, GRAST meetings and during meetings with CRO

• Ensure all CTA regulatory activities are in alignment with the strategic direction of the GRA TA, GRAST and the SET

• Translate the CTA strategy into a plan and is responsible for executing the plan

• Liaise with other GRA functions as well as with key functions within Clinical Development Operations, GCSP, Clinical Trial Supply, Legal and CRO to ensure CTA process is performed on time and with high quality documents

• Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders

• Contribute to and/or review key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSUR

• Manage interactions with Health Authorities and is the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs

• Ensure accurate and timely tracking and archiving of CTA activities in the CSL systems

• Anticipate regulatory trends related to clinical trial applications to develop regulatory Intelligence capabilities and share lessons learned to ensure development of a first in class study strategy

• Coaches and trains Global Regulatory Clinical Study Leads and Specialists

• Develop, maintain and improve CTA processes, drive development and improvement of new systems, solutions and procedures related to CTA activities:

• Be a Subject Matter Expert for CTA related topics and ensure continuous process improvement

• Responsible for the generation, maintenance and provision of metrics on workload as well as KPIs for key CTA activities and analyze consolidated data

• Support budget development and workload planning related to CTA activities

Education:

Advanced degree (MSc, PhD or equivalent) in life science, pharmacy, or other health/medical related area preferred)

Other degrees and certifications considered if commensurate with related regulatory or clinical research experience.

Experience:

• As a guide, a minimum of 7+ years’ experience in managing Clinical Trial and Clinical Trial Applications

• Experience Working with or Working within a Contract Research Organization, preferred

• Broad knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations

• Experience in automation of CTA processes, knowledge in automated and tech driven processes

• Experience in developing KPI for CTA-related activities

• Experience in vaccines would be ideal

• Knowledge of ICH guidelines/GCP, EU CTA regulation (CTR536/2014), related regulatory guidelines and experience in scientific/medical research

• Demonstrated sound judgment and flexible approach to managing situations

• Customer service focus

• Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation

• Ability to identify the ‘big picture’ and opportunities/major issues and link day to day tasks with long term goals

• Demonstrated ability to deal with rapid change

• Proven ability to deliver to successful outcomes to internal and external customers while meeting business objectives

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com

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