- Mylan Inc. Head of Regulatory Affairs - North America - 17000451 For Us, It’s A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a DifferenceAt Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
- Responsible for development and implementation of the regulatory strategy for the United States and Canada across the Mylan portfolio of generics, brand and OTC products. Oversight of the day-to-day operations and of the planning, preparation, review and evaluation of documents for submission to the FDA
- Oversee the processes governing preparation of major regulatory filings, including INDs, BLAs, NDAs, and ANDAs, as well as timely completion of routine regulatory submissions required for maintenance of INDs/CTAs, BLAs, and NDAs/MAAs, such as adverse event reports, annual reports and CMC, nonclinical and clinical amendments to INDs/CTAs, BLAs, and NDAs/MAAs to ensure high quality with an overall objective to receive approval within the shortest timeframes possible.
- Provide advice, regulatory guidance and status reports to senior management, as appropriate. Interpret FDA regulations, policies and procedures. Provide guidance on regulatory Agency expectations and timelines to facilitate management decision-making and launch planning.
- Maintain positive relationships with FDA as primary liaison on submissions, communications and specific projects. Represent Regulatory Affairs at FDA Pre-Approval Inspections. Interact with outside legal counsel and consultants, as needed, on regulatory issues.
- Provide strategic regulatory guidance for new and approved products, as needed. Provide input to minimize regulatory issues and help prevent unnecessary regulatory delays. Oversee Distribution Regulatory Compliance activities and coordination across Mylan facilities, including State Licensing, DSCSA, and DEA compliance.
- Maintain awareness of all regulatory activities and current statuses regarding new and approved drug products. Stay current with state-of-the-art-standards on the regulatory process. Actively monitor and assess impact of new FDA requirements; support development of Mylan’s positions/comments to help shape regulatory policy.
- Provide daily direction to Regulatory Affairs staff including Regulatory professional leaders, administrative, documentation support, labeling, and regulatory submission management functions. Manage employee development activities.
- Responsible for maintaining operational/expense budget, headcount budget, and capital budget for the North America Regulatory Affairs department. Review monthly budget performance.
- Interact with other functional areas and executive leadership as needed to provide guidance with respect to regulatory issues. Maintain current knowledge of regulations and other issues that affect products and industry. Disseminate and discuss with key staff, as appropriate, and in a timely manner.
- Ensure process and resources are in place to allow timely review of internal documentation such as change control information, method transfer packages, batch records documentation, validation protocols, and reports.
Make Our Values Your ValuesMylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
- Bachelor’s degree (or equivalent), and a minimum of 15 years of experience in Regulatory Affairs is required. Related experience and/or education may also be considered.
- 10 years of experience in a Regulatory Affairs leadership role where direct relationships with regulatory authorities were built and/or maintained is required.
- Must possess strong communication, critical thinking and interpersonal skills.
- Must possess expert-level knowledge and interpretation of FDA regulations and industry guidances, policies, and procedures pertaining to the submission, approval and post-approval processes.
- Ability to read and interpret comprehensive and intricate research documents. Ability to clearly and succinctly write scientific/regulatory summaries and technical correspondence. Ability to work with executives and clearly communicate abstract concepts.
- Previous management experience is required.
- Must be willing and able to travel domestically up to 20% or as needed.
- May be required to stand, walk, stoop; bend; kneel; and climb steps.
- Proficiency in speaking, comprehending, reading and writing English is required.