What are the responsibilities and job description for the Senior Director, Regulatory Affairs CMC position at CSL?
Position Description Summary: The Senior Director of Regulatory Affairs CMC and Compliance provides leadership and oversight, strategic planning and effective planning for the Seqirus Global Regulatory CMC and Compliance function within Global Regulatory Affairs. The role reports to the Global Head of Regulatory Affairs for Seqirus and contributes to the vision, goals and continual improvement of GRA.
Main Responsibilities & Accountabilities: Provide strategic Regulatory Affairs CMC leadership and direction to effectively support global development projects and marketed products
Review CMC sections of IND/IMPD/CTA, NDA/BLA/MAA and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development and lifecycle maintenance including resolution of key CMC regulatory issues and to expedite approvals of product. Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintain the highest quality.
Work closely with CMC colleagues to develop CMC regulatory submission strategies, review content, and maintain submission timelines to meet business objectives. Accountable that information submitted in marketing applications meets regional CMC requirements, allowing maximum manufacturing flexibility with minimal unanticipated questions. Direct resources to ensure all appropriate CMC regulatory aspects across teams to support license approval/maintenance and change control requests are delivered to agreed timelines.
Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders. Identify key risks to the business associated with submission data and information packages and communicate to senior management well defined risk mitigation strategies.
Build, mentor and train a high performing team in support of their technical and career development needs. Manage contract staff and vendors as needed to support regulatory activities.
Manage activities of the Global RA CMC including resources, budgets, information management systems and planning, in line with the Global Regulatory Affairs activities.
Establish, manage and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues. Develop and implement department policies, processes and SOPs.
Qualifications & Experience: Degree in Biological Science or a related subject, preferably with a second degree at postgraduate level (MS or PhD)
Minimum of 15 years regulatory experience, including at a senior management level in the pharmaceutical/biotechnology industry. Global regulatory experience including knowledge of and application submission processes and product life cycle management activities. Demonstrable experience of effective delivery of objectives in a complex matrix environment. Experience in establishing and building a high-performing team.
Requirements: Proven experience of product development and manufacturing with established CMC Regulatory Affairs capability through development and lifecycle management. Demonstrated ability to handle complex global CMC issues through continuous change and improvement. Ability to articulate complex Regulatory CMC issues and support global development and commercialization of early and late stage programs.
Strong interpersonal skills to develop effective working relationships with internal stakeholders and cross-functional project teams.
Demonstrated track record of effective influencing and negotiating with regulatory agencies, industry bodies and in a variety of settings. Flexibility and ability to prioritize and manage multiple tasks simultaneously
About CSL Seqirus
Strong analytical skills, problem solving ability and presentation skills
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
Main Responsibilities & Accountabilities: Provide strategic Regulatory Affairs CMC leadership and direction to effectively support global development projects and marketed products
Review CMC sections of IND/IMPD/CTA, NDA/BLA/MAA and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development and lifecycle maintenance including resolution of key CMC regulatory issues and to expedite approvals of product. Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintain the highest quality.
Work closely with CMC colleagues to develop CMC regulatory submission strategies, review content, and maintain submission timelines to meet business objectives. Accountable that information submitted in marketing applications meets regional CMC requirements, allowing maximum manufacturing flexibility with minimal unanticipated questions. Direct resources to ensure all appropriate CMC regulatory aspects across teams to support license approval/maintenance and change control requests are delivered to agreed timelines.
Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders. Identify key risks to the business associated with submission data and information packages and communicate to senior management well defined risk mitigation strategies.
Build, mentor and train a high performing team in support of their technical and career development needs. Manage contract staff and vendors as needed to support regulatory activities.
Manage activities of the Global RA CMC including resources, budgets, information management systems and planning, in line with the Global Regulatory Affairs activities.
Establish, manage and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues. Develop and implement department policies, processes and SOPs.
Qualifications & Experience: Degree in Biological Science or a related subject, preferably with a second degree at postgraduate level (MS or PhD)
Minimum of 15 years regulatory experience, including at a senior management level in the pharmaceutical/biotechnology industry. Global regulatory experience including knowledge of and application submission processes and product life cycle management activities. Demonstrable experience of effective delivery of objectives in a complex matrix environment. Experience in establishing and building a high-performing team.
Requirements: Proven experience of product development and manufacturing with established CMC Regulatory Affairs capability through development and lifecycle management. Demonstrated ability to handle complex global CMC issues through continuous change and improvement. Ability to articulate complex Regulatory CMC issues and support global development and commercialization of early and late stage programs.
Strong interpersonal skills to develop effective working relationships with internal stakeholders and cross-functional project teams.
Demonstrated track record of effective influencing and negotiating with regulatory agencies, industry bodies and in a variety of settings. Flexibility and ability to prioritize and manage multiple tasks simultaneously
About CSL Seqirus
Strong analytical skills, problem solving ability and presentation skills
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus