Now Hiring :Clinical Data Manager III: New York NY

 
Location: New York, New York
Posted On: 8/8/2017
Job Code: 8320-1
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Job Description
 
Job Description:
***True Job Title: Regulatory Affairs ***

Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.

• Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies; For assigned products, contribute to and provide review/approval for safety aggregate reports as required locally.

• Direct liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements, and commitment closures.

• Develop and implement regulatory strategies to support/maintain registrations. Maintain product licenses across all product platforms.

• Understand regulatory environment and communicate priorities to global/regional stakeholders

• Deliver project regulatory strategy, risk assessment, and PRS for assigned projects/products

• Ensures business compliance and implementation of and adherence to Regulatory standards.

• Lead and/or direct team discussion regarding project status in senior management forums.

• Prepare IRD and CTD submissions for NCE and line extensions including liaison with contributing groups and review of components. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, minimize resource demands while maximizing overall project delivery time and probability of success.

• Ensure that product maintenance activities (product renewals, AQRT's, regulatory queries, etc.) are managed and responded to in line with product role, consistent with departmental procedures an including liaison with other functional groups to ensure that response targets are met.

• Liaise with internal and external technical experts responsible for preparation of expert documentation for inclusion in IRD and CTD submissions and apply regulatory expertise to enable preparation of high quality documentation.

• Advise on the development of regulatory documentation that meets relevant regulatory requirements and ensure that the documentation meets relevant regulatory requirements and that compliance with departmental procedures is assured.

• Co-ordinate with regional and country strategists the receipt, distribution and response to regulatory queries, in line with product role, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.

• May lead preparation for, and attend where appropriate, meetings with regulatory authorities, including preparation of background materials, logistical organization and assisting in preparation of meeting minutes.

• Ensure that comprehensive records of communications and regulatory status are maintained.

Emerging Market (EM) specific qualifications
• Contribute to the preparation of global regulatory strategies and plans for the targeted EM countries, including review of existing regulatory guidelines, competitor products and relevant literature.

• Develop detailed understanding of EM regulatory guidelines and technical requirements and a broad understanding of the global regulatory environment.

• Ensure that line management are advised of progress in regulatory filings in EM

• Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.

• Lead and/or direct creation or revision of labeling per medical position or as instructed by Health Authority.

Position Comments visible to MSP and Supplier:
• Health Authority
• Global labeling
• Global safety
• Global medical


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Additional Skills:
• Proven examples of delivery across a product’s lifecycle with demonstrable contribution in Regulatory
• Affairs.
• Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes.
• Experience managing multiple products simultaneously and different stages of the product lifecycle.
• Experience in successfully communicating with major Health Authorities, including leading and participating in such interactions.
• Proven ability to consistently deliver to time, cost and quality standards.
• Strong written and verbal communication skills

onsite or remote
Category:IT  code:new
 
 
Job Requirements
 
 
Compliance, Management, Direct3D
 

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Contact Details
 
Recruiter
Ajaykrishnan Ks
 
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