Clinical Regulatory Affairs Director - Remote

Cambridge, MA 02139

Post Date: 06/29/2018 Job ID: 30110 Industry: Other Area(s)

Clinical Regulatory Affairs Director - Remote

The Regulatory Affairs Director (RAD) is responsible for the global submission and approval of oncology biosimilars. Key responsibilities include: 
-     Lead submission and approval of 1-2 oncology biosimilars in EU/US and ROW by 2020 
-     Lead health authority interactions along with technical experts to facilitate approval 

The Regulatory Affairs Director possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with Product Development Teams (PDT) and relevant internal and external stakeholders. 

•     Lead and responsible for planning, developing and managing the biosimilar regulatory dossier for global submission. 
•     Lead and responsible for timely global submission of the biosimilar dossier. 
•     Lead and responsible for effective regulatory interactions in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements. 
•     Lead and responsible for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk and mitigation measures. 
•     Lead and responsible for post approval submission activities including product maintenance, supply and compliance activities 

•     Be the champion and point of contact for biosimilar related regulatory queries 
•     Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advice Product Development Teams (PDT) and commercial teams accordingly. 
•     Partner with marketing company staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. 

•     Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Product Development Teams (PDT) and commercial team 
•     Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality. 
•     Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project. 


Minimum biological drug submission experience, maybe even biosimilar.

•     Bachelor’ s degree in a science related field and/or other appropriate knowledge/experience. 
•     Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.). 
•     More than 5 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas. 
•     Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority. 
•     Proven leadership and program management experience. 
•     Ability to think strategically and critically evaluate risks to regulatory activities. 
•     Ability to work strategically within a complex, business critical and high profile development program. 
•     Successful contribution to a major regulatory approval at a global or regional level. 
•     A scientific and clinical understanding of the regulatory sciences. 
•     Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. 

Key Relationships 
Internal /External
•     PDT leader 
•     PDT members 
•     JV BOD members 
•     GMLs 
•     Commercial team members  

 •     Health authorities 
•     Key industry groups 
•     Policy forums
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