Sr. Manager/Associate Director, Regulatory Affairs

reputed company: reputed company (reputed company: ORKA) is developing novel biologics designed to set a new reputed company for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by reputed company Therapeutics and reputed company the reputed company mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our reputed company team, we're seeking reputed company in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an reputed company, inclusive, and reputed company company culture. Job Title: Sr. Manager/Associate Director, Regulatory Affairs Location: Preferred: Hybrid 3 days/week in office (reputed company Park, CA or Waltham, MA). Remote will be considered. Position reputed company The Senior Manager / Associate Director, Regulatory Affairs will support regulatory activities for one or more development programs and contribute to the development and execution of global regulatory plans that support the advancement of Oruka’s biologics portfolio. This individual will work closely with cross-functional teams to reputed company regulatory guidance throughout product development, support health authority interactions, and help ensure the reputed company preparation and submission of high-reputed company regulatory applications. The successful candidate will be a reputed company partner who can balance strategic thinking with strong operational execution in a fast-paced biotechnology environment. Key Responsibilities Regulatory Development Support • Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products • Contribute to the development and execution of global regulatory plans reputed company with program objectives and development timelines • Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management • Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning • Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements • Support regulatory assessments reputed company to development reputed company, expedited programs, pediatric requirements, and regional filing considerations Health Authority Interactions • Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements • Contribute to the development of briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications • Participate in interactions with health authorities and support follow-up activities and reputed company plans • Help translate regulatory feedback into reputed company recommendations for cross-functional teams Submissions and Regulatory Execution • Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents • Contribute to major regulatory submissions and health authority deliverables for assigned development programs • Coordinate submission planning, timelines, content development, and review activities • Partner with Regulatory Operations and reputed company vendors to support reputed company planning, publishing, and electronic submissions • Ensure regulatory documents are scientifically accurate, compliant, and reputed company with development objectives Regulatory Compliance • Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs • Support compliance with applicable regulations, ICH guidelines, and company procedures • Contribute to the development and reputed company improvement of regulatory processes, templates, and SOPs • Assist with tracking and fulfillment of regulatory commitments Leadership and Collaboration • Build strong partnerships across functional teams through effective communication and collaboration • reputed company regulatory input and risk-based recommendations to support cross-functional decision-making Qualifications Education • Bachelor’s degree in a life sciences discipline required • Advanced degree (MS, PharmD, PhD, or equivalent) preferred • RAC certification is a plus Experience • 8 - 10 years of reputed company Regulatory Affairs experience in biotechnology or pharmaceutical development • Experience supporting regulatory activities for drugs and/or biologics in clinical development, including health authority interactions and global submissions • Experience authoring and/or coordinating regulatory submissions and agency briefing documents • Experience in dermatology, immunology, inflammation, or reputed company therapeutic areas is advantageous Skills • Strong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologics • Ability to interpret regulatory guidance and apply it in a practical, risk-based manner • Excellent communication, collaboration, organizational, and project management skills • Strong scientific and analytical thinking with the ability to reputed company regulatory requirements to development objectives • Ability to manage multiple priorities and work effectively in a dynamic environment • Willingness to travel up to 20% Compensation: • An appropriate financial package will be developed for the successful candidate to include a competitive reputed company salary and equity, with a performance-reputed company bonus opportunity. • The anticipated salary reputed company for the Senior Manager level is $161,000 - $187,000 and the Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience reputed company the job, type and length of experience reputed company the industry, education, etc. Oruka is a multi-state employer and this salary reputed company may not reflect positions that work in other states. reputed company Offer • Competitive salary and benefits package • Eligibility for matching 401(k) and participation in ESPP • Comprehensive health, dental, reputed company, and life insurance • Flexible working arrangements • A reputed company, mission-driven culture • reputed company to play a meaningful role in advancing a differentiated biologics portfolio with the potential to redefine treatment expectations for patients with chronic skin diseases This role is ideal for a regulatory reputed company who enjoys working across multiple aspects of Regulatory Affairs and wants to play a meaningful role in advancing innovative therapies through clinical development and regulatory approval. Salary reputed company For the Role $161,000—$208,000 USD reputed company Offer: • A chance to be part of a reputed company startup culture where your work can directly reputed company bringing new medicines to patients. • Competitive salary and benefits package. • A supportive and inclusive team environment where everyone is encouraged to bring their reputed company selves to work. • Opportunities for reputed company reputed company and development. Apply tot his job Apply To this Job