CSL Limited

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Global Regulatory Lead, GRA GPS

at CSL Limited

Posted: 10/20/2019
Job Status: Full Time
Job Reference #: R-101877
Categories: Other/General
Keywords: company

Job Description

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Responsibilities

The Global Regulatory Lead (GRL) within GRA Global Product Strategy (GRA GPS) is responsible for providing strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for assigned projects.

•The GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategy.
•As the primary regulatory interface within CSL Behring for Global Regulatory Affairs (GRA) on specific development projects, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team / Project Strategy Team (CPT/PST), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development team to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables.
•The GRL is accountable for the delivery of successful regulatory license applications globally, including new product development and product life cycle management related to new indications. The GRL may also provide clinical related input for late life cycle products independent of development phase.
•In partnership with Regional Leads, the GRL is also accountable to pro-actively support the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned therapeutic areas and products.

Qualifications

Responsible for regulatory strategic input and decisions necessary to ensure development and execution of successful global regulatory strategies, submissions and approvals for assigned project(s) at all stages. Additionally, appropriate competitive decision making is applied when evaluating and proposing solutions to product development changes.

Leads the Global Regulatory Affairs Strategy Team (GRAST) by:

  • Being accountable for documentation of global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO), and ensures it is current.
  • Ensuring regional engagement in Global Regulatory Strategy development and execution of said strategy.
  • Resolves and aligns internal GRA boundary inputs for GRAST members
  • Meets regularly with individual GRAST members to understand the functional aspects of the project
  • Utilizes appropriate departmental tools to consistently run and execute GRAST meetings
  • Prioritization of global regulatory submissions based on team input

Responsible for development of core regulatory position and documentation necessary to support  all interactions with global health authorities, as required to support product’s development.  Represent the company, as required, at key regulatory agency meetings, regulatory advisory committee meetings or equivalents.

Serve as the Primary Regulatory Interface on the Core Project Team/Project Strategy Team (CPT/PST), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA.  This includes provision of regulatory oversight of all aspects of chemistry, manufacturing and controls, non-clinical and clinical regulatory development and incorporation of appropriate CPT/PST & CDT deliverables into the global regulatory strategy.  Provide regulatory leadership into the development of the Target Product Profile and together with the Global Strategic Labeling Lead, develop and maintain the Developmental Company Core Data Sheet (dCCDS) or CCDS.

Reviews and approves internal and external documentation to support the development and commercialization of responsible product(s), including protocols, development safety update reports (DSUR)/ Product Safety Update Report (PSUR), annual health authority updates, clinical trial applications (CTA) / IND amendments, CTD documentation and post-approval change documents. 

Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), to senior review committees such as GRA Strategy Management Review Team (SMRT), Therapeutic Project Review Committee, and Therapeutic Area Leadership Team, as appropriate.

Leverage effective relationships with regulatory experts and consultants to proactively optimize regulatory outcomes.

Leadership: Actively promotes appropriate leadership behaviors in one’s work, including Driving Performance, Building Productive Teams & Creating the Future

Capabilities

A bachelor’s degree (4 year university degree) in pharmacy, biology, chemistry, pharmacology clinical medicine or related life science is required.  An advanced degree (MS/MBA, PhD or MD) is preferred.

EXPERIENCE

  • Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
  • Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
  • Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (ie. EU, US, Japan)
  • Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU).
  • Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
  • Demonstrated experience in working with multiple stakeholders.
  • Prior clinical regulatory foundation and/or management experience is preferred.

COMPETENCIES

  • Strong ethics and integrity
  • Self-motivated, pro-active and strategically focused.  Creates innovative strategies and able to make decisions and think globally, while evaluating multiple program aspects including impact of decisions/strategy.
  • Demonstrates professional confidence in his/her abilities and understanding of regulatory affairs.
  • Demonstrated success in internal and external regulatory negotiations
  • Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
  • Proven ability to build and lead effective, well integrated, collaborative teams andempower team members.
  • Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters.
  • Contributes to a first class results oriented team by setting clear expectations and holding people accountable.
  • Creative problem solving/issue resolution skills with the willingness to take risks and act decisively
  • Able to facilitate brainstorming in teams and open to creative thoughts of others
  • Cross-cultural sensitivity demonstrating understanding and acceptance of different cultural parameters

Worker Type:

Employee

Worker Sub Type:

Regular


With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

If you are an individual with a disability and need a reasonable accommodation for any part of the 

application process, please click here

CSL is an Equal Opportunity Employer

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CSL does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site.  All employment businesses/agencies are required to contact CSL's human resources department to obtain prior written authorization before referring any candidates to CSL.  The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and CSL.  In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of CSL.  CSL shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.



Posted 30+ Days Ago

Full time

R-101877