Remote Director, Senior Director, Regulatory Affairs, Immunology

Summary

Join IGM Biosciences as the Director of Regulatory Affairs to lead global regulatory strategies for immunology programs, develop high-quality submissions, and represent the company in cross-functional development teams.

Requirements

• Must have relevant immunology therapeutic area experience
• A minimum of 10 years of Regulatory Affairs experience in the biopharma industry; Significant experience in the therapeutic area of immunology/autoimmunity is strongly preferred
• BS or higher degree in the life sciences; Advanced academic degree (Master’s or PhD) is a plus
• Experience as a GRL providing strategic regulatory advice to project teams for the global development of products through all stages of development
• Extensive experience filing IND/CTAs and some experience with BLAs/NDAs/MAAs
• Extensive knowledge of regulatory requirements for all stages of drug development in a global environment
• Demonstrated success in proactively managing collaborative relationships with key internal and external stakeholders, including FDA and other Health Authorities
• Proven ability to successfully lead regulatory meetings
• Ability to work independently and to be innovative in tackling strategic and operational challenges
• Experience managing direct reports is preferred
• Must have strong verbal and written communication skills
• Must be proficient with computer and standard software programs used in Regulatory Affairs

Responsibilities

• Develop and implement competitive and effective global regulatory strategies for various immunology products including clinical, nonclinical and CMC aspects and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, BLAs, and MAAs) for IGM early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval
• Represent Regulatory Affairs on assigned cross-functional development teams
• Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions
• Provide updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications, approvals, and their impact on IGM programs
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges

Benefits

• Medical, dental, and vision insurance
• IGM covers the full premium amount for our employees and their dependents
• FSA (Flexible Spending Account) or HSA (Health Savings Account)
• STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
• Voluntary Life Insurance and Disability
• 401(k) Plan with Employer Match
• 3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays
• Cell phone & internet subsidy
• Employee Referral Bonus Program
• Annual training budget for professional development
• Commuter Benefit
• Annual bonus program
• New hire equity
• Annual refresh grants
• ESPP (Employee Stock Purchase Plan)