Vice President, Regulatory Affairs PC 884

Miltenyi Biomedicine•Waltham, MA

7d•$295,600 - $347,764•Onsite

About The Position

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’s. Overall, the role will focus on meeting company established goals and timelines in collaboration with global regulatory strategy.

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.
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.

Nice To Haves

ATMP experience is a plus.

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.