Director, Regulatory Affairs

Employer
Viela Bio
Location
Gaithersburg, MD
Posted
Jun 21, 2019
Ref
2019-041
Required Education
Doctorate/PHD/MD
Position Type
Full time

Director, Regulatory Affairs - Job Ref ID: 2019-041

Summary of Position

Viela Bio is seeking a talented and highly motivated Director Regulatory Affairs. This person will be responsible for supporting the Head of Regulatory in the execution of the regulatory strategy for the Viela Bio product portfolio.

Key Responsibilities:

The Director, Regulatory Affairs reports to the Senior Director of Regulatory Affairs and works with the Global Product Teams (GPTs), supporting the development and execution of the regulatory strategy for the Viela Bio product portfolio. 

  • Develop and implement innovative and effective regulatory strategies that may include pursuance of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and Priority Medicines Scheme (PRIME) designation, in support of bringing our client’s portfolio of compounds through development and to the market.
  • Independently represent the regulatory affairs function at GPT meetings and provide updates regarding ongoing regulatory activities as well as collaborate with project management to drive these activities to completion. 
  • Work collaboratively with cross functional team members (Clinical Operations, Research, and Translational Science) and key internal stakeholders to prepare for regulatory submissions including coordination of meeting requests, writing and management of briefing documents, leadership at both rehearsal and meetings/TCs, and appropriate follow-up and integration of results into global strategy.
  • Conducts regulatory review of clinical documents, including: protocols, informed consent, and clinical study reports.
  • Gather and analyze regulatory intelligence and independently keep abreast of new and changing regulations/guidance.
  • Develop, write, and implement standard operating procedures and/or instructions as needed.
  • Serve as the primary contact with regulatory agencies for assigned projects.
  • Interacts with company partners and consultants for various regulatory matters as needed.

Desired Skills and Experiences:

  • Strong working knowledge of US regulatory processes. Experience with global (EU/Japan) regulatory processes is a plus. 
  • Must have in-depth knowledge of regulatory requirements and guidance documents, including FDA regulations, ICH and EMA guidelines/directives. 
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations. 
  • Strong judgment and decision-making skills in making critical go/no-go decisions.
  • Ability to influence across functions or in a matrix environment requiring strong peer relationships and to provide leadership in situations of shared accountability or high level of ambiguity.
  • Self-aware and adaptable, adept at recognizing his/her own strengths, limitations and motivations.  A strong results-driven personality with a high level of enthusiasm and energy capable of acting with authenticity and ego maturity and of actively seeking feedback and recognizing impact on others.
  • Demonstrated ability to influence across functions or in a matrix environment requiring strong peer relationships and to provide leadership in situations of shared accountability or high level of ambiguity.
  • Willingness and ability to adhere to the Company’s Approach, Culture and Values
  • Strong independent research capabilities using available paper and electronic resources.
  • Proficient user of standard MS Office suite (Word, Excel), experience using electronic document management systems and document review tools required. 

Education:

  • Advanced degree (Pharm.D., or Ph.D. preferred) in life sciences or a relevant discipline with at least 5-8 years of experience in a regulatory affairs function in a biopharmaceutical company.