Director, Clinical Regulatory Affairs

Location
San Diego, California
Posted
Apr 29, 2021
Ref
oTJsdfw1
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Director, Clinical Regulatory Affairs is responsible for assisting the VP of Regulatory Affairs with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals.  The position is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities.  This position would be held accountable for establishing strategic plans, policies, and procedures to ensure Avidity fulfills its obligations and commitment.  

Responsibilities include:  
  • Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members representing the regulatory department in the development process
  • Communicate requirements and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets
  • Communication of regulatory strategies and plans to ensure alignment with the overall project plan and business strategy
  • Direct and lead regulatory execution strategies and regulatory submissions
  • Contribute to compliance related functions such as GxP projects, governance initiation, draft and review SOP’s, review of contracts, and quality/supply agreements
  • Oversight and management of external regulatory vendors and regulatory resources
  • Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings
  • Assist in the management and oversight of regulatory activities relating to clinical trials
  • Assist with leadership of the regulatory team and provide guidance to the wider organization
  • Advise on labeling, promotional review and other post marketing/commercial regulatory activities
  • Assure compliance with regulatory reporting requirements
  • Represent the Company’s interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business
  • Perform other duties as required  
Desired Knowledge and Abilities:  
  • Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activities
  • Excellent knowledge of regulatory, GxP, compliance, laws, and regulations for pharmaceutical products
  • Experience developing products, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc.
  • Proven ability to establish strategy and to translate it into an effective, long term action plan
  • Demonstrated success in effectively leading regulatory teams
  • Thorough understanding of the regulatory process from development through commercialization
  • Strong project management skills
  • Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development, Regulatory and Quality Control
  • Established track record with evidence of excellent project management, problem solving, collaborative, leadership, and communication skills
  • Strong written and oral communication skills
  • Able to grasp complex technical issues and make sound decisions based on data and information from various sources
  • Ability to foster and promote internal collaboration  
Education and Experience:   
  • Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
  • Minimum of 8-10 years of experience in pharmaceutical / biotech
  • Minimum 4-6 years in a management role within Regulatory

 Avidity offers very competitive benefits and is an Equal Opportunity Employer.