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VP Regulatory Affairs, US Biomedicine at Miltenyi Biotec Inc

Posted in Other 30+ days ago.

Location: Waltham, Massachusetts





Job Description:

Description

VP Regulatory Affairs, US Biomedicine


Your Role:


Within this role, you will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts. You will oversee industry-specific practices, ensure all government and company regulations are being met and working with regulators on creating practices and regulatory awareness for novel therapies. Overall, you will focus on meeting company established goals and timelines in collaboration with global regulatory strategy.


Key Responsibilities:



  • Establishes, leads, and executes innovative regulatory strategy for clinical programs in US, in preparation for BLA and sBLA filings.

  • Proactively communicates with FDA, establishes working relationship with relevant review groups

  • Leads Biomedicine US regulatory inspection preparation. Advises and coordinates CMC related regulatory activities

  • Assesses the company's compliance with industry regulations, both external and internal, as applicable to US

  • Develops and advises on new policies for the company.

  • Identifies, assesses and communicates potential project challenges and conduct risk mitigation strategies pertaining to regulatory affairs.

  • Maintain a current knowledge of industry-specific regulations and guidance.

  • Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.

  • Member of global cross-functional teams which require experienced interpretation of applicable /FDA/ Health Canada/ICH/Global regulations to ensure compliance within the organization.

  • Recommends direction and leads key operations and new initiatives in collaboration with local and global stakeholders.

  • May lead team members that provide regulatory affairs content and requirements for regulatory submissions and reviews this content for conformance with established requirement.

  • Manages and develops staff, if required, including staff professional development and project oversight accountability.

  • Represents Miltenyi Regulatory Affairs in meetings and leads preparation activities for meetings with Health Authorities on regulatory affairs related matters

  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provides solutions to prevent recurrence of issues.

  • 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.

  • Ensuring all necessary regulatory applications are filed timely.

  • Creating functional strategies and specific objectives for the regulatory affairs in US and developing budgets/policies/procedures to support the regulatory affairs infrastructure/activities.

  • Proven ability to liaise with Regulatory Agencies - has demonstrated experience interacting in-person, by phone, and through written correspondence with said agencies.

  • Team-science oriented, data-driven, and patient-centric engendering credibility and confidence within and outside the company.


Education and Technical Skills Requirements:



  • B.S. or higher degree (s) in the sciences, or health related field. Advanced scientific degree preferred and 10 years of pharmaceutical/biotechnology industry regulatory experience with technical management experience; or equivalent combination of education and experience

  • Extensive experience providing regulatory leadership through the complete clinical development process (early clinical trials through registration)

  • 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.

  • Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.

  • Ability to analyze and interpret scientific and technical information, as well as regulatory documents


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, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 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.


Work Environment


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. This job requires the person to occasionally travel to visit other sites.


Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.


We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.


Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity







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