Regulatory

  • location: Lexington, MA
  • type: Contract
  • salary: $66.03 - $77.69 per hour

job description

Regulatory

Associate Director, Global Regulatory Affairs (CMC) I

Job Summary

The CMC Regulatory Affairs Network Strategy Implementation Team Lead will provide leadership and be the Regulatory CMC point of contact for major projects in the Network Strategy Implementation workstream, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization. This will include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3.

Job Responsibilities

  • Serve as the team lead for Network Strategy Implementation leads
  • Serve as a liaison between the network project teams and the GRA CMC Product Lead
  • Provide CMC RA leadership within RA and on cross-functional CMC teams
  • Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
  • Describe the essential daily job functions and include % of time spent on each.
  • Provide CMC regulatory strategy for proposed changes or other related activities for commercial programs. (60%)
  • Facilitate timely regulatory approvals by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
  • Lead other functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
  • Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)
Education & Qualifications

  • B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
  • 7 - 10 years of drug development experience including and/or significant strategic experience in CMC regulatory affairs with a strong biologics background.
  • Demonstrated leadership in regulatory strategy and experience in regulatory interactions
  • Ability to manage complex projects, timelines and teams in a matrix team environment.
  • Strong analytical and problem solving skills.
  • Ability to lead a team of multi-facility and multi-function employees to a successful outcome.
  • Strong communication and leadership skills.
  • Strong interpersonal, communication, influencing, and negotiation skills
  • Strong computer skills, excellent writing, organization, and presentation skills.
  • Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
  • Be Positive
  • Be Accountable
  • Be Results-oriented
  • Be An Excellent Manager of Self and Others
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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