Senior Manager, GRA Development
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
* Develops/authors and leads the execution global regulatory development and registration strategies as the primary member of project team for assigned products throughout clinical development cycle gaining buy in from key stakeholders.
* Develops and applies a comprehensive understanding of global RA regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
* Serves as regulatory lead (GRL) on the global clinical development team (GCDT) for individual project of responsibility. Can have multiple projects depending on development stage and complexity.
* Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.
* Manages interactions with international Heal
th Authorities, as appropriate. Acts as the primary regulatory authority contact, successfully negotiating RA matters directly and indirectly for assigned projects/programs.
* May mentor Associate level personnel Objectives
* Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development.
* Leads the regulatory working team and represents team at GDT; ensures global regulatory strategy is written and executed according to plan.
* Accountable for all submissions and approvals for project(s) of responsibility. Independently negotiates RA matters with regulatory agencies, directly and indirectly for all assigned projects/programs.
* Accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
* Responsible for ensuring complete submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA). Manages the preparation of responses to regulatory agency queries / oversees completion of activity by others.
* For the project(s) of responsibility, collaborates with global colleagues and other regional counterparts ensuring critical deliverables to territories are provided outside of region to ensure regional execution of the strategy as agreed within the global regulatory strategy
* Fully understands regulatory requirements and their implication on assigned programs, and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
* Generally serves as regulatory lead on the global clinical development team (GCDT) for individual project(s) of responsibility. Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
* Generally the primary regulatory authority contact for project(s) of responsibility. May be the lead regulatory representative at Agency meetings
* Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
* Manage individual projects with greater complexity
* Provides regulatory expertise and guidance in the due diligence review of licensing opportunities. Represents Regulatory Affairs on assigned teams.
* Identifies and proposes solutions to management for any resource gaps for project responsibilities
* Ensure regulatory compliance of marketed products.
* Mentors and coaches Regulatory Associate level staff and facilitates their growth and development. Qualifications:
* BSc Degree, preferred. BA accepted.
* Extensive pharmaceutical industry experience. This is inclusive of sizable regulatory experience or combination of broad regulatory and/or related experience.
* Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
* Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
* Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
* Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
* Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
* Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
* Must work well with others and within global teams.
* Able to bring working teams together for common objectives.
* Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.
Please apply at: Application URL: http://www.aplitrak.com/?adid=bWljaGFlbC5tY2ZhcmxhbmUuNjQ4OTcuMzE2N0BtcGkuYXBsaXRyYWsuY29t