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Regulatory Affairs Leader
Ref No.: 18-08218
Location: Waltham, Massachusetts
Position Type:Contract
Start Date / End Date: 06/11/2018 to 06/14/2019
Job Title: Regulatory Affairs Leader
Duration: 1 year
Location: Waltham, MA

Job Description:

• Regulatory strategy management opportunity to for global biological clinical programs within the complement portfolio, including INDs and BLAs for orphan indications. This position will be responsible for leading and/or supporting global strategy and submissions.
• Responsible for developing and implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs
• Responsible for leading or supporting Agency meetings.
• Responsible for leading and coordinating all aspects of regulatory submissions relevant to assigned projects or programs
• Identify and assess regulatory risks associated with product development for assigned programs. Assist in defining strategies to mitigate risks
• Guide the organization and preparation of clear and effective submissions.
• Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards.
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on specific projects.
• Function as assigned project team member.

• A minimum of 10 years in the Pharmaceutical Industry, and a minimum 5 years regulatory management experience (Biologics)
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate excellent communication skills.
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
• Demonstrate effective cross-cultural awareness and capabilities.
• Some direct experience in interfacing with relevant regulatory authorities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Excellent knowledge and understanding of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.

• BA/BS/University degree required, Life/Health Sciences preferred.

Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
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