Director Of Regulatory Operations in Gaithersburg, MD at DISYS

Date Posted: 6/30/2018

Job Snapshot

Job Description

Hi,



Greetings From DYSIS!!!



My name is Aravind. I represent the Talent team within DISYS (www.disys.com).  DISYS is a global technology and business services consulting firm specializing in Business and IT Consulting & Staffing Services to commercial and government customers.  We are a $350 million private firm with 20 branches in the US and 13 international locations servicing over 200 Fortune 1000 clients.



If you are interested in the below position, feel free to reach me.



Title         : Director Reg Operation


Location: Gaithersburg, MD


Contract: 12+ Months



Job Description:


Key responsibilities:
Lead submission and approval of 1-2 oncology biosimilar 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.

Regulatory Submission:
• 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

Regulatory Environment:
• 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.

Leadership:
• 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.

Education, Qualifications, Skills and Experience:
• 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 (to AZ or team) External (to AZ)
• PDT leader
• PDT members
• JV BOD members
• GMLs
• Commercial team members • Health authorities
• Key industry groups
• Policy forums

Job Requirements

Hi,



Greetings From DYSIS!!!



My name is Aravind. I represent the Talent team within DISYS (www.disys.com).  DISYS is a global technology and business services consulting firm specializing in Business and IT Consulting & Staffing Services to commercial and government customers.  We are a $350 million private firm with 20 branches in the US and 13 international locations servicing over 200 Fortune 1000 clients.



If you are interested in the below position, feel free to reach me.



Title         : Director Reg Operation


Location: Gaithersburg, MD


Contract: 12+ Months



Job Description:


Key responsibilities:
Lead submission and approval of 1-2 oncology biosimilar 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.

Regulatory Submission:
• 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

Regulatory Environment:
• 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.

Leadership:
• 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.

Education, Qualifications, Skills and Experience:
• 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 (to AZ or team) External (to AZ)
• PDT leader
• PDT members
• JV BOD members
• GMLs
• Commercial team members • Health authorities
• Key industry groups
• Policy forums

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.