Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
The Global RA Head, CMC & Compliance is a member of the Global RA Leadership Team and reports directly to the Global Head of Regulatory Affairs. This role contributes to the vision and goals for GRA, and ensures that the strategic objectives for Global RA are delivered by providing leadership and oversight, strategic planning and effective management for the Global CMC & Compliance function.
Scope of the Role
- Contribute to company Global Regulatory Strategy through participation on the Global Regulatory Affairs Leadership Team (GRALT) and SMRT.
- Work closely with the VP Global Regulatory Affairs to develop and maintain an effective Global Regulatory Affairs organization through continuous improvement initiatives that deliver business excellence.
- Provides strategic and operational regulatory direction on projects requiring general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and Regulatory Authority interactions.
- Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Able to articulate complex Regulatory CMC issues and support global development and commercialization of early and late state programs.
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
- Reviews CMC sections of IND/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.
- Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key CMC regulatory issues and to expedite approvals of product.
- Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.
- Proactively manages critical CMC issues, taking leadership for the regulatory contribution.
- Develops and implements department policies, processes and SOPs.
- Provide strategic CMC Regulatory guidance regarding global regulatory requirements for global clinical development and registration.
- Compile, review, approve and submit CMC and marketing registration applications, amendments, and supplements.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Act as primary regulatory representative at key internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
- Manage contract staff and vendors as needed to support regulatory activities.
- Provide create and innovative solutions while being an advocate for compliance.
- Directs teams which provide the primary interface with Product Development, Nonclinical Safety and Manufacturing for global development products including in licensed assets.
- Responsible for managing direct agency interface for CMC product specific aspects for all development and in-licensed assets and for ensuring effective negotiation of CMC agreements on behalf of product Development, Quality and Manufacturing.
Identifies and communicates risk to product development teams, establishing appropriate risk mitigation plans.
- Provides leadership to Regulatory Affairs as part of CMC Regulatory Leadership team
Accountable for CMC regulatory strategies and submission of global CMC applications aligned with business needs for new chemical entities and new dosage forms
- Embraces and drives change in regulatory solutions, seeking new and effective approaches which are aligned with emerging technology, regulatory expectations and applicable laws and regulations.
- Coaches and mentors staff across CMC Regulatory Affairs on lifecycle management in CMC Ensures records are maintained for CMC aspects of global licenses.
- Manage the functional budget, resource plans and monitor progress to ensure strategic objectives of the Division are achieved.
- Oversee the development of strong working/partnering relationships with key regulatory agencies in terms of new submissions initiatives by working through the local country regulatory managers (i.e. FDA, Health Canada, EMA, TGA). Represent Seqirus at meetings with Regulatory Agencies
- Direct the growth and professional development of the regional Regulatory Strategy team members, including succession planning for critical roles with the regional and global regulatory affairs group.
Key Relationships (both internal and external)
- Internal departments including QA, QC and Manufacturing & Supply Chain
- External regulatory authorities in Australia and internationally
- Position has at least 4 direct reports and up to 20 indirect reports across the business in all manufacturing site locations
- Indirect reporting line to VP Quality and SVP Operations
- Location: based at one of three Seqirus manufacturing sites (must be on site)
- Working hours – 10 day fortnight
- Domestic and international travel will be required
Position Qualifications and Experience Requirements
- A degree in Biological Science or Health Sciences, with preference for a second degree at postgraduate level (MS or PhD), or demonstrated experience
- A minimum of 10 years of regulatory affairs experience, preferably supported by additional pharmaceutical/biotechnology industry experience
- Extensive and proven experience of product development, manufacturing with established CMC Regulatory Affairs capability through development and commercial supply, lifecycle management, interactions with Regulatory Authorities, leading and managing regulatory teams, and developing and implementing complex CMC regulatory strategies.
- Strong business acumen and demonstrated ability to make sound decisions that translate strategy into action.
- Demonstrated ability to coordinate plans to resolve issues and mitigate risk
- Excellent verbal and written skills; able to analyse, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to the internal and external stakeholders.
- Strong negotiating skills and ability to think creatively to develop effective solutions.
- Excellent interpersonal skills, demonstrated ability to develop important relationships with key stakeholders, good conflict management and negotiation skills
- Established working knowledge of regulatory guidelines and regulations (US and international) and of eCTD structure and regulatory writing skills
THE ROLE MAY BE BASED IN HOLLY SPRINGS, LIVERPOOL, OR PARKVILLE.