Director of Regulatory Affairs - Immunology

Position Description: The Director of Regulatory Affairs will serve as the global regulatory lead (GRL) on several immunology programs and will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy growing pipeline of programs.   This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required. 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 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 company programs. Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges. Qualifications: Level is commensurate with experienceMust 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 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 $220,000 - $270,000 a year This range reflects the job's characteristics, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location. Actual individual pay is determined by demonstrated experience and internal equity alignment. We offer a fast-paced, collaborative, team-based work environment.    One of our top priorities is to maintain our employees' and their families' health and well-being. To achieve this goal, we offer comprehensive benefits with a variety of options: Medical, dental, and vision insurance. We 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)