Senior Director, Global Regulatory Affairs Biologics 6/6/2020
JOB DESCRIPTIONAPPLY 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 DIFFERENCE
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:
* This role will guide, develop, and execute global regulatory strategies and plans. This position will interface with key internal and external stakeholders including Project Management, Clinical, Preclinical Regulatory CMC, Devices and Pharm Sciences Teams as well as interface with Regulatory Agencys Worldwide including US, EU, Canada, Japan and other regulatory agencies as required to build regulatory strategies as part of the biosimilars portfolio.
* Provide leadership to the Leadership Team to develop tactical plans for Biosimilars/biologic products as assigned.
* Execute regional regulatory strategic and tactical activities in accordance with development milestones.
* Ensure the timely submission and approval of Regulatory deliverables to support the Biosimilars/biologic portfolio, such as CTA's, IND's and annual reports.
* Ensure timely build submission and approval of Marketing Authorizations.
* Lead preparations and interactions for Regulatory Authority meetings. Provide high quality and current regulatory advice to project teams.
* Review technical documentation/dossiers for compliance with legislation and provide feedback on the suitability of the documentation for obtaining Marketing Authorizations.
* Manage the design and development and implementation of Company Regulatory processes and procedures, where appropriate.
* Lead preparation, submission and review of Marketing Authorizations, in accordance with relevant directives, regulations, guidelines National requirements and Mylan company policies and procedures.
* Manage the day to day regulatory work to ensure that project deadlines/priorities are met.
* Monitor the global regulatory environment for policy/guideline updates and assess any potential impact of the development program. Monitor the external competitor environment and build knowledge into project strategies.
* Liaise across the organization with senior leaders.
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 of Science degree (or equivalent) and 10 - 15 years of experience. However, a combination of experience and/or education will be taken into consideration.
* Must possess knowledge and experience of BLAs, INDs, CTAs, Annual Reports and associated requirements.
* Must possess excellent communication skills, both oral and written. Good interpersonal skills with the ability to multitask is required. Strong technical background and organizational skills are essential. Accuracy and attention to detail required. Strong work ethic. Computer skills including Microsoft Word, Excel and PowerPoint are preferred.
* Must possess the ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
* Must possess the ability to work with managers or directors and communicate ambiguous concepts. Ability to present to a high level of the organization and groups outside of the organization.
* Must possess the ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
* This 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.
* Proficiency in speaking, comprehending, reading and writing English is required.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran. USA-WV-Morgantown