Director, Biologics

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POST DATE 8/16/2016
END DATE 12/22/2016

Mylan Inc Morgantown, WV

Mylan Inc
Morgantown, WV
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats easy. If you are a doer and have a passion for serving others, we want to talk to you.


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. Heres how this role will help:

* Formulate, lead and drive the regulatory strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.

* Provide regulatory expertise to biologic products across multiple therapeutic areas and technical initiatives

* Provide expert regulatory affairs knowledge and insure implementation in the global Bio-similar strategy

* Participate with the CMC teams in the development of clinical programs and protocols required to meet the Health Authorities (HA) requirement for product approval

* Participate with CMC, Manufacturing, Quality, Safety and clinical teams in the development of programs and protocols required to meet the Health Authorities (HA) requirement for product approval

* Direct and oversee the preparation, review and submission of INDs/CTXs/CTAs, amendments, reports and correspondences (including but not limited to safety reports, Annual Reports, Protocol Amendments, and Information Amendments).

* Supervise and review the preparation, Health Authorities (HA) filing and maintenance of dossiers including original applications, amendments, supplements, variations, renewals, annual reports, labeling, responses to HA inquiries/comment letters, safety reports and other Agency correspondences. Act as the primary liaison with the HAs regarding issues with regard to assigned projects. Responsible for HA interactions including telephone conferences, meetings, appeals, administrative hearings and general communications.

* Review pharmacology, toxicology, pharmacokinetic clinical reports, protocols, investigator brochures, consent forms and clinical drug releases for completeness, consistency and compliance with regulatory requirements.

* Provide regulatory oversight with regard to the preparation, submission and revision of new and revised labeling for branded products.

* Manage the regulatory aspects pertaining to the compilation, submission and review of information required to fulfill Phase IV regulatory commitments for approved products.

* Provide advice and counsel to applicable company personnel regarding the regulatory aspects associated with the drug development, review, approval, and marketing processes.

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:

* A B.A. or B.S. degree in science or health-related discipline and 10 years pharmaceutical industry experience, an advance degreed preferred. The successful candidate will have a strong knowledge of regulations and guidance pertaining to biologics. However, a combination of experience and/or education will be taken into consideration.

* Must possess excellent working knowledge/experience in regulatory submissions and approval processes for Biopharmaceuticals and ability to deal with complex clinical and CMC regulatory issues and requirements. Should be experienced within regulatory affairs in the field of biologic clinical development, including responsibilities for successful prosecution of development milestones and/or marketing authorization (e.g. EOP1/EOP2/preNDA(BLA) meeting facilitation and negotiation, label negotiations, regulatory responses). Demonstrated established relationships with key FDA (CBER and CDER) stakeholders (e.g. project managers, reviewers and/or decision makers)

* Must have excellent project management, interpersonal and consensus gathering skills, a strong work ethic and exemplary written and verbal communication skills. Must be well organized, attentive to detail, even-tempered and capable of providing support and direction to others. Applicable computer skills in a Windows-based environment are also necessary.

* Position functions within a high-level global team structure with no direct supervisory requirements. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include planning, assigning, and directing work.

* Must be proficient in spoken and written English. Ability to read and interpret comprehensive and intricate research documents. Ability to write complex reports and high-level business correspondence. Ability to work with peers, business contacts, and corporate management in order to communicate moderately complex concepts. Ability to present to a high level of the organization and groups outside of the organization.

* Ability to add, subtract, multiply, and divide, compute ratios and percentages, compute statistics, draw and interpret bar graphs.

* Ability to apply consistent, sound, and reasoned judgement based upon regulatory and business requirements, as well as, past experience. 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

* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

* Typically sitting at a desk or table or travelling via automobile, bus, train, airplane, etc. May require long periods of walking, standing, stooping, or climbing stairs in an industrial plant setting.

* The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

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 30,000 worldwide, we can make a difference. We encourage you to visit 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.

Job Posting: Sep 22, 2016, 1:01:02 PM
Unposting Date: Ongoing.