Vice President, Regulatory Affairs *PC 884 at Miltenyi Waltham, Massachusetts

Job Title

The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts. The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance. Overall, the role will focus on meeting company established goals and timelines in collaboration with global regulatory strategy.

Essential Duties & Responsibilities:

• Establish, lead, and execute innovative regulatory strategy for all 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 related regulatory activities and ensuring all 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 experienced interpretation of applicable FDA/ Health Canada/ICH/Global regulations to ensure compliance within the organization.
• Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement. Manage and develop staff, if required, including staff professional development and project oversight accountability.
• Represent Miltenyi US Regulatory Affairs in meetings and lead preparation activities for meetings with Health Authorities on regulatory affairs related 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 related 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 current 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 current 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 within and outside 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 perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach 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 close 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. All 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.