美国大型药企招聘Director of Global RA Strategy

• 新设立的职位
  

• 负责精神类药物管线
  

• 汇报给senior director

• 工作地暂定新泽西（也可以谈异地工作）

Summary:

The Director, Global Regulatory Affairs will lead the development of US and Global regulatory strategies for the Company’ next-generation Neurology Portfolio from early development through post approval.  This role will require: (1) careful understanding of current Regulatory environment (competitive intelligence and Health Authority guidance), (2) partnership with International Project Team members to ensure successful execution of INDs/CTAs/NDAs/MAAs, and most importantly, (3) frequent interactions with global Health Authorities to obtain agreement on the innovative strategies proposed to support getting the products to market expeditiously.

The Director, Global Regulatory Affairs will foster drug development by facilitating the identification and resolution of scientific and regulatory issues with global Health Authorities such as the FDA, EMA and PMDA.  The individual who assumes this role must possess the ability to work in a matrix organizational structure, show agility in problem solving and be able to work successfully with all levels of management.

The Director will lead the creation of global regulatory strategy for their product(s), lead the preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs, lead the creation of responses to Healthy Authority requests for information and interact directly with global Health Authorities.

PRIMARY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

· Assuming the role of Global Regulatory Lead (GRL) for assigned products in the Neurology Business Group Portfolio

· Leading the planning, execution and assessment of product life cycle management activities from early development through post approval

· Proactively formulating regulatory strategies that provide for streamlined development and approval timelines, while accurately interpreting and reflecting regulatory and corporate guidelines

· Leading the planning, preparation for and conduct of meetings with Health Authorities for all assigned products. Initiating and responding to Health Authority contacts to ensure expedient and efficient review and approval of products

· Leading the creation of and ensuring all documents submitted to Health Authorities are strategic, complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance as well as presented in a way that facilitates Health Authority review

· Identifying, monitoring and resolving regulatory issues and reporting progress to management

· Acting as the Global Regulatory Lead on International Project Teams, inputting into team discussion to ensure appropriate regulatory strategies are implemented

· Leading the Global Regulatory Subteam for assigned products, closely collaborating with nonclinical, CMC, growth market, and other regional regulatory leads on the overall strategy for a product

· Leading and coordinating all regulatory activities required for submissions to Health Authorities for assigned products

EDUCATION AND SKILLS REQUIREMENTS:

· B.A./B.S. in the sciences or health related field with an advanced degree preferred

· A minimum of 10 years of industry Regulatory Strategy experience required

· Demonstrated knowledge of drug development process and strategic thinking skills are essential

· Knowledge of US and global regulations and specific Health Authority guidance documents

· Experience with preparing IND/CTA/sNDA/Type II variation submissions and briefing packages for Healthy Authority meetings is essential

· Experience with successful NDA, MAA and/or BLA filings preferred

· Strong understanding of pediatric development requirements globally

· Prior experience directly interacting with the global Health Authorities is preferred, including leading Health Authority meetings

· The ability to bring divergent views together to align on common objective

· The ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors

· The ability to analyze gaps in current work processes and recommend enhancements

· Demonstrated ability to solve complex problems

· The ability to work within and lead cross-functional team meetings and work streams

· Strong written and verbal communication skills

· A personality that engenders enthusiasm through challenging circumstances

· This role has the potential to manage a direct report based on business needs

· Approximately 10% travel based on business needs