Job Details

Requisition Number 18-0151
Post Date 6/20/2018
Company Akcea
Title Director, CMC Regulatory Affairs
Employment Type Full Time
Description

Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.

Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada. 

DIRECTOR, CMC REGULATORY AFFAIRS

The Director CMC Regulatory Affairs is expected to serve as the global product leader for CMC regulatory strategy for Akcea programs. This will include formulating and implementing global CMC regulatory strategies for the development of commercial and development products, lead CMC regulatory activities for assigned projects in line with global requirements, as well as to coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.

Responsibilities:

  • Develop and implement CMC Regulatory strategies for assigned projects and provide advice and strategic guidance to development teams.
  • Serves as the CMC regulatory lead on relevant project teams and subteams.
  • Plans, manages, and executes all CMC regulatory activities for assets in various phases of development.
  • Establish, in collaboration with the CMC technical team, a harmonized set of CMC templates for global regulatory submissions which satisfy global regulatory requirements.
  • Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
  • Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
  • Interacts directly and indirectly with internal and external partners on CMC regulatory topics, as necessary.
  • Ensures line management and key stakeholders are apprised of ongoing developments.

Qualifications:

  • BS degree required, MS, Ph.D or Pharm D preferred
  • 8 -10 years industry experience
  • 5-7 years’ experience specifically in Regulatory Affairs CMC

Requirements:

  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings.
  • Understanding of scientific principles and regulatory/quality systems and requirements relevant to global vaccine development. 
  • Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to Manager.
  • Solid working knowledge of relevant domestic and global regulations and guidance
  • Exercise outstanding judgment in all areas of responsibility
  • History of successful interactions with global regulatory authorities
  • Energetic, self-motivated and a hands-on professional with a strong work ethic
  • Capable of performing independently and thinking analytically and creatively to solve problems
  • Effectively lead and manage multiple time-sensitive projects
  • Ability to be a true team player working across functions for achievement of shared goals
  • Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
  • Productive and successful in an intense work environment
  • Willing to travel domestically and internationally up to 20%

 

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com 

Reference #18-0151

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Akcea Therapeutics, Inc. is proud to be an EEO employer.

 

 

Apply On-line
Send This Job to a Friend