This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., CMC Regulatory Affairs in other regions, Quality Assurance, Technology Division, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders.
Essential Job Responsibilities:
* Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
* Member of global teams/task forces which require expert interpretation of applicable FDA/EMA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders.
* Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
* Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders.
* Reviews global regulatory submissions for consistency and quality across regions including detailed input on CTD Module 3 documents for clinical trial and registration filings and DMFs.
* Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
* Provides regulatory guidance for compendial issues, both USP and global (e.g., Ph.Eur. and JP) and monograph preparation.
* Responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions
* Develops an environment to enable each member of the Regulatory Affairs CMC Americas team to optimally operate in the matrix environment of RA, Global Medical and Development, Technology and Astellas.
* Responsible for mentoring, training and supervising RA staff within RA CMC Americas.
* Effectively delegates responsibilities to achieve goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.
* Member of the CMC Regulatory Affairs and the Regional Regulatory Affairs Leadership teams and collaborates to contribute to the planning of mid- and long-term strategy.
* Ensure the alignment between RA strategy and mid- and long-term Astellas strategy and conformity with Corporate guidelines.
Quantitative Dimensions:
Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions.
Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications on operations revenue, and/or credibility.
Failure to perform functions for commercial products could have substantial implications on operations, sales, revenue, and/or credibility of Astellas up to 1 billion dollars. Typical development programs include budgets in excess of 100 million dollars per project.
Position is responsible for supervision of 4-10 regulatory CMC professionals.
Organizational Context:
Reports to the VP regulatory affairs Americas; dotted line to head of global RA CMC or vice versa.
Position is responsible for supervision of 4-10 regulatory CMC professionals (manager, senior manager, associate director).
Requirements
Qualifications:
Required:
* BS in Chemistry or equivalent degree; advanced scientific degree strongly preferred
* 12+ years industry experience; pharma, CRO or academic with at least 5 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities.
* Expert technical and regulatory knowledge of the requirements for compliance with GMPs and an in depth knowledge of regulatory CMC submission requirements in the Americas region, and globally where relevant, with a strong understanding of the application of ICH and other guidances.
* Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
* Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
* Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
* Ability to navigate a globalizing organization and to act globally and regionally as appropriate.
* Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations.
Preferred:
* Proven leadership skills
* Experience leading in a multi-national environment
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