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Associate Director, Regulatory Affairs

US-Any US location
Permanent
Reference: 018106
Description


Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late-phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.


 

Mapi is adding an Associate DirectorUS Regulatory Affairs to our Strategic Regulatory team!  This position has responsibility for managing strategic regulatory operations and providing expert advice on the guidelines and regulations to clients within the US Regulatory environments.

 

Major responsibilities include:

Develops strategic regulatory plans for client drug development programs under supervision of Director

Plans and prepares all submission types (e.g. CTA, IND, NDA, BLA, Annual Reports, expedited safety reports, etc) to regulatory authorities with minimal supervision in adherence with applicable Acts, Regulations and Guidance for submission to government agencies (focus on FDA). 

Facilitates submission approvals through effective communication and negotiation with client, government agencies, and project team.

Reviews and/or authors study reports, clinical protocols, Investigator's Brochures and CTD summaries, ensuring that all documents are accurate and consistent with applicable regulations and guidance.  Reviews draft submissions for regulatory content and editorial viewpoint.

Responsible for managing project workflow for INDs and NDAs including prioritizing project objectives, and establishing timeframes for projects with clients with guidance from Director.  

Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.

Participates in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies.  

Builds positive working relationships with clients and government agency contacts.  Interacts with potential clients to develop new business.

Identifies project issues and develops alternate strategies for presentation to client.  

Provides clients with advice in response to their queries, based on regulatory experience and area of expertise.

Other duties and responsibilities as assigned. 


Qualifications:

  • B.Sc. in a Biological, Medical, Chemical or Engineering Science. An advanced degree is preferred.
  • Minimum of 5 years of pharmaceutical / biologics development experience in the US regulatory environment and preferably multiple jurisdictions (EU and Canada).
  • Knowledge and understanding of the development process for pharmaceutical and biological products including:  CMC, non-Clinical and Clinical
  • Direct experience and working knowledge of a range of US regulatory submission types.
  • Demonstrated ability to interpret and utilize the Code of Federal Regulations and other FDA and ICH documents to prepare regulatory / product development strategies.
  • Experience in people management is preferred

 

Knowledge/Skills/Abilities include:

Displays knowledge of drug development and regulatory requirements to deliver solutions to clients. 

Identifies regulatory non-compliance and issues involving subject safety and provides solutions. 

Distinguishes between good practice and regulatory requirements. 

Intermediate to advanced working knowledge of MS Word, Adobe Acrobat Standard with ability to troubleshoot, including knowledge of the eCTD environment.

 

 



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