Associate Director, Regulatory Affairs

The Company:

We have partnered with an exciting biotech sponsor company who are looking to hire an experienced Associate Director of Regulatory Affairs to develop and drive complex regulatory strategies. This nimble, growing biotech company is focused on developing precision antibody therapies for a range of serious diseases. Join an experienced leadership team with a bright future in developing an exciting pipeline of life changing medicines.

Reporting to and working closely alongside the Executive Director of Regulatory Affairs, this role is a full-time and highly strategic leadership position. This position is based in our Waltham headquarters, with flexibility to work from home up to 2 days per week. Up to 10% travel may be required. The successful candidate for the Associate Director of Regulatory Affairs will be primarily, but not exclusively responsible for the following:

• Establish regulatory presence and act as a respected resource leadership across partner organizations and senior management
• Propose and develop creative strategies to expedite drug development, including early indication research and early development path research
• Develop global, regulatory strategies addressing different regions, and all regulatory sub-disciplines including CMC and labeling
• Lead complex submissions such as initial INDs/CTAs and PIPs
• Develop Investigator’s Brochures and interact with leaders in Nonclinical, Clinical and Quality to align on submission strategy
• Represent Regulatory and project teams before governance committees providing briefings and aligning team strategies with overall corporate leadership and direction
• Lead 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
• Leads teams to constructively confront drug development issues and develop effective, practical solutions
• Present on complex regulatory information to the company, partner organizations and represents the company at other local regulatory events
• Provide regulatory guidance to help establish and then complete team goals
• Anticipate needs and initiates complex work, guiding in partnership with relevant project teams
• Maintain line reporting structures to employees and or vendors including supervising junior regulatory team members
• Articulate regulatory strategies, educates, and persuade senior leaders with respect to regulatory strategies and issues
• Communicate regulatory strategies to the team as pursued by other organizations working with competing assets or in the same targeted disease space
• Incorporate new information from regulatory intelligence and interpret intelligence to others

Requirements

• BA/BS degree required - advanced degree preferred, especially in a relevant scientific discipline
• 6-8 years’ experience in Regulatory Affairs within the biotech or pharmaceutical industry
• Experience in multiple disciplines related to drug development strongly preferred
• Demonstrated experience leading teams in producing complex, global regulatory submissions
• Direct 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 simultaneously
• Demonstrated communication skills to lead project teams. Experience communicating in-depth information persuasively to Sr. Managers. Strong written and verbal communication skills
• Ability to relate to Sr. Management and Sr. Leaders in other disciplines in constructive ways to advance company goals
• Ability to develop positive relationships with and manage external vendors
• Skillful communicator with ability to influence organizational leadership and partners
• Demonstrated leadership in managing, authoring, or presenting on regulatory issues to departments or larger audiences
• Solid understanding of the eCTD and production of electronic submissions
• Skilled in MS Word, PowerPoint, Project
• RAC designation a plus

Our client values a diverse workforce and 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.