Job Description
We are currently seeking a Director, Strategic Biogenerics Regulatory Affairs at our Canonsburg, PA location. The Director, Strategic Biogenerics Regulatory Affairs will enable the availability of Mylan’s affordable, quality Biogeneric products to 7 billion people around the globe by helping to shape and influence the regulatory environment to allow the development and approval of interchangeable biologic products, by directing successful regulatory interactions and regulatory submission strategies and by providing clear regulatory guidance to the internal team on biologics.
Desired Skills & Experience
Provide key strategic regulatory direction to help Mylan senior leadership shape the development of sound biogeneric requirements and policy across the globe.
Establish and ensure the submission strategy and execution for Mylan’s biogenerics portfolio.
Directs the strategy (time, tone, and content) of interactions of the regional and Biologic teams with the respective Health Authorities including the request, preparation and execution of meetings with Health Authorities for product specific issue and policy related issues.
Provide critical input to the execution of Mylan’s Biogeneric Program by translating the impact of regulatory environmental changes/trends on Business and Strategic Plans.
Develop regulatory goals to align with business goals as they pertain to due diligence/business development opportunities, risk management, development, product life cycle management, regulatory submissions and approvals.
Collaborate with Operational Regulatory colleagues both in Biologics and throughout the Globe to set ideal regulatory pathways for success, growth, including planning and developing regulatory capabilities and strategies to support the business objectives.
Where appropriate, influence and shape the regulatory environment, as well as industry positions.
Coordinate on regulatory policy relating to worldwide medical device laws and regulations and work closely with trade associations and professional committees.
Takes a leadership role in the strategic planning activity with respect to regulatory requirements and the submission of regulatory documents.
Provide daily oversight, counsel and guidance to regulatory affairs staff members and to other functional areas and manage regulatory activities for Biogenerics products to meet both regulatory requirements and company objectives.
The candidate must have experience in regulatory affairs in the generic, biotech, pharmaceutical or biogenerics industry with the respective managerial and leadership experience and should have a track record of successful interactions among regulatory and health authorities on an international level. Demonstrated advocacy and negotiation skills, thorough understanding of the biogenerics drug development process, knowledge of the developing biogenerics regulations and guidelines is highly preferred. A background in generics is strongly preferred but not required.
A minimum of a Bachelor's degree (or equivalent) and 5 years of experience is required. A degree in science and 10 years of experience is preferred. A Master's degree (or equivalent) and 12 years of Biologics experience is strongly preferred. However, a combination of experience and/or education will be taken into consideration.
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Email: jobs@aarenconsultants.in
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