Associate Director, Regulatory Affairs

Location
02451, Waltham
Salary
very competitive
Posted
Nov 19, 2021
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Visterra is a clinical stage biotechnology company committed to developing innova­tive biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases and autoimmune conditions.  Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. Our focus is on early development, first-in-human and early phase 2 studies.  We are de­veloping a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan.  Visterra has approximately 90 employees, and is located in Waltham, Massachusetts.

Summary

Having achieved a mastery of the fundamentals of regulatory affairs, the Associate Director will have the key role of integrating technical knowledge into their creative strategy to guide Sr. Leaders to achieve major company goals.  Reporting to the Executive Director, Head of Regulatory Affairs, The Associate Director establishes regulatory presence and is a respected resource for Sr. Leadership across partner organizations and Sr. Management. 

The ideal candidate will have an advanced degree, 6-10 years of biotechnology experience of success conducting global development for biologics. Experience in multiple disciplines (Regulatory, Quality, Nonclinical) is strongly preferred.  The Associate Director must have superior writing and computer skills. This is a full-time position located at Visterra’s offices in Waltham, MA.

Responsibilities

  • Develops and maintains global, regulatory strategies addressing different regions, and all regulatory sub-disciplines including CMC and labeling.  May direct regulatory professionals in preparation of sections of strategy; participates in developing Target Product Profiles; aligns these strategies with overall corporate strategy.
  • Leads complex submissions such as initial INDs/CTAs, PIPs, developing Investigator’s Brochures and interacts with Sr. Leaders in Nonclinical, Clinical and Quality to align on submission strategy.
  • Imagines, leads, and proposes creative strategies to expedite drug development, including early indication research and early development path research.
  • Proposes and leads teams to plan for critical HA meetings (Pre-IND, EOP1, Scientific Advice), leading teams to produce Briefing Books; prepares for HA meetings including determining meeting objectives, key messages; represents the company with Health Authorities including negotiations on complex issues related to early development.
  • Provides a presence and direction for cross-functional project development teams; Provides regulatory guidance to help establish and then complete team goals; Anticipates needs and initiates complex work, guiding it to completion via subteams/ad hoc project teams.
  • Represents Regulatory and project teams before governance committees providing briefings and aligning team strategies with overall corporate leadership and direction.
  • Participates in Department Leadership by having dotted line reporting structures to employees and or vendors; May supervise junior regulatory team members.
  • Manages complex projects from inception to completion that aligns with company goals and  requires influencing and guiding leadership from other disciplines.
  • Articulates regulatory strategies, educates, and persuades Sr. Leaders with respect to regulatory strategies and issues. In doing so, becomes fully aware of and communicates to the team the regulatory strategies pursued by other organizations working with competing assets or in the same targeted disease space.
  • Leads presentations on regulatory information to the company, partner organizations and represents the company at other local regulatory events.
  • Incorporates new information from regulatory intelligence; leads teams and the organization by interpreting intelligence to others.
  • Demonstrates excellent presentation skills to present complex regulatory information to Sr. Management, Sr. Leaders and peers.
  • Leads teams to constructively confront drug development issues and proposes effective, practical solutions.
  • Some travel (up to 10%) may be required to attend meetings, conferences and industry events.

Requirements

  • BA/BS degree required.  Advanced degree preferred, especially in scientific disciplines.  RAC designation a plus.
  • Associate Director level requires at least 6 years’ experience. Advanced degrees may be counted for experience, in all cases priority will be given to the level of experience and demonstrated leadership.  Experience in multiple disciplines related to drug development strongly preferred.
  • Demonstrated experience leading teams in producing complex, global regulatory submissions. 
  • Excellent experience authoring and reviewing regulatory documentation for biologics and understanding core requirements of US FDA and ICH guidelines.
  • Ability to initiate, plan and manage multiple, major projects which address company goals.
  • Demonstrated communication skills to lead project teams.  Experience communicating in-depth information persuasively to Sr. Managers.  Strong written and verbal communication skills.
  • Solid skills in MS Word, PowerPoint, Project and a solid understanding of the eCTD and production of electronic submissions. 
  • Ability to plan in advance, set goals, determine objectives, enlist, and lead others to drive large, complex, critical regulatory submissions to completion to achieve department or company goals.
  • Ability to relate to Sr. Management and Sr. Leaders in other disciplines in constructive ways to advance company goals.
  • Ability to articulate the need for, identify, negotiate with, hire, and manage vendors. 
  • Established leadership skills to influence Senior leaders in the organization.
  • Demonstrated leadership in managing, authoring, or presenting on regulatory issues to departments or larger audiences.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.