At 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:
- Manage the preparation and review of new Abbreviated New Drug Applications and amendments and post approval submissions to ANDAs for upper management review.
- Manage data and information including monitoring submission schedules for adherence to deadlines for Research & Development.
- Oversee internal and external reviews of new Abbreviated New Drug Applications.
- Prepare amendment responses to FDA comment letters. This includes circulating comment letters for review and scheduling meetings to discuss response(s) and explain deadlines to other departments such as Product Development, Chemistry and Purchasing.
- Manage pending ANDAs including ensuring that all regulatory requirements and/or commitments are met with respect to obtaining approval of new products and tracking changes to ensure that any additional information or revised documentation are submitted in accordance with regulatory requirements.
- Manage ANDAs post-approval including performing thorough reviews of Annual Reports to ANDAs and serving as the sign-off for upper management.
- Recommend the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation.
- Interact with the Labeling team, as necessary, to ensure consistency between the labeling and CMC sections of applications, etc.
- Manage employees by serving as a mentor and providing direction to direct reports including scheduling and distributing the regulatory workload, answering questions and providing guidance. Also monitor direct reports, if applicable, to ensure quality performance and provide performance feedback.
- Provide regulatory advice and coaching on ANDA submissions, approval and post-approval processes to Product Development, Quality Assurance, and Quality Control.
- Review internal documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports and maintain internal regulatory databases as required.
- Maintain current knowledge of regulations and other issues that affect products and the industry. Disseminate and discuss with appropriate staff in a timely manner
Make Our Values Your Values
Mylan 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:
Minimum of a Bachelor's degree (or equivalent) and 5-6 years of relevant regulatory experience and supervisory skills. However, a combination of experience and/or education will be taken into consideration.
Must possess expert-level knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA guidance for Industry and have the ability to interpret these to apply to Mylan procedures. Must also possess expert-level knowledge of the regulatory process pertaining to drug development, registration, review and approval. Must possess knowledge of Mylan’s approach with regards to interactions with the FDA.
Must possess strong analytical, organization, technical writing, and communication skills. Must have the ability to multi-task and have meticulous attention to detail. Must possess strong computer skills and working knowledge of Microsoft Office Suite, Documentum, and Lotus Notes.
Must be able to manage various projects and employees in order to meet submission deadlines.
Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.
Sedentary lifting requirements.
Proficiency in speaking, comprehending, reading and writing English is required.