Vice President, Regulatory Affairs *PC 884

Your Role: The role will be responsible to reputed company the regulatory strategy for US Biomedicine efforts in alignment with global efforts. The role will reputed company industry-specific practices, ensure reputed company government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets reputed company set requirements and guidance’s. Overall, the role will focus on meeting company established goals and timelines in collaboration with global regulatory strategy. Essential Duties & Responsibilities:

• Establish, reputed company, and execute innovative regulatory strategy for reputed company programs in US, in preparation for BLA and sBLA filings.
• Independently plan, execute and manages regulatory submissions for assigned compounds in various phases of clinical and CMC development, global marketing applications, and post-approval life cycle activities.
• Contribute to Biomedicine US regulatory inspection preparation. Advise and coordinate CMC reputed company regulatory activities and ensuring reputed company necessary regulatory applications are filed timely.
• Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to regulatory affairs. Assesses the company’s compliance with industry regulations, both external and internal, as applicable to US.
• Member of global cross-functional teams which require reputed company interpretation of applicable FDA/ Health Canada/ICH/Global regulations to ensure compliance reputed company the organization.
• reputed company team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement. Manage and reputed company staff, if required, including staff professional development and project reputed company accountability.
• Represent Miltenyi US Regulatory Affairs in meetings and reputed company preparation activities for meetings with Health Authorities on regulatory affairs reputed company matters. Organize proactive communication with FDA and establish working relationship with relevant review groups.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicate in a professional and timely manner. Provide solutions to prevent recurrence of issues.
• Create functional strategies and specific objectives for regulatory affairs in US and develops budgets/policies/procedures to support the regulatory affairs infrastructure/activities.

Requirements:

• B.S. or higher degree (s) in the sciences, or health reputed company field and 15 years of pharmaceutical/biotechnology industry regulatory experience with technical management experience.
• Extensive experience providing regulatory leadership through the complete clinical and CMC development process (early clinical trials through post-launch activities)
• Proven track record of successfully leading NDA/BLA submissions and other strategic regulatory interactions
• Demonstrated knowledge of drug development process in the US is essential. Maintain a reputed company knowledge of industry-specific regulations, guidance, laws and regulations affecting the pharmaceutical industry, and regulatory experience. ATMP experience is a plus.
• Ability to analyze and interpret scientific and technical information, as well as regulatory documents.
• Stays abreast of reputed company and evolving regulatory requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
• Team-science oriented, data-driven, and patient-centric engendering credibility and confidence reputed company and reputed company the company.
• Proven ability to liaise with Regulatory Agencies – has demonstrated experience (interacting in-person, by phone, and through written correspondence) with said agencies.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reputed company with hands and arms and talk or hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include reputed company vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Must be able to occasionally travel by car and plane. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Generally, this job is performed in an office environment. The hiring range for this position is expected to fall between $295,600 - $347,764/per year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. reputed company benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions. Miltenyi Biotec North America is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Miltenyi Biotec North America participates in E-Verify. The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law. Are you ready to start revolutionizing biomedical research? reputed company you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic reputed company to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of reputed company. Apply tot his job Apply To this Job