Posted to MedZilla on 12/5/2019


Takeda Pharmaceuticals

US-MA, Senior Associate, GRA CMC SR0040823-MZ


 
 

The Senior Associate of GRA CMC will support the Global Regulatory CMC Lead in preparation of development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes.

  • With supervision, supports the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. Supports Regulatory teams for assigned products throughout clinical development and commercial lifecycle.
  • Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance.
  • Interacts and effectively communicates with other internal and external colleague.

Accountabilities:

  • With supervision, executes regulatory submissions for assigned projects.
  • Helps define CMC content (data and documentation) requirements for regulatory submissions.
  • With supervision, participates in Health Authority interactions and supports preparation activities for meetings with Health Authorities on CMC related matters.
  • Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner.
  • Evaluates change proposals for global regulatory impact with supervision and may support planning of variations and amendments.

Education and Experience Required:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 2 yrs work experience in a supportive role; experience with pharmaceuticals or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) is valuable.
  • Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is valuable
  • Demonstrates attention to detail and problem-solving abilities.
  • Excellent written and oral communication skills required.
  • Experience working with cross-functional teams (or an equivalent), preparation of high quality documents (i.e., for submissions), and an ability to execute on activities

Physical Demands:

  • Routine demands of an office based environment.
  • Manual dexterity required to operate office equipment (ie computers, phones, etc)

Travel Requirements:

  • Ability to attend offsite meetings that may involve overnight stay

Additional Information:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 2 yrs work experience in a supportive role; experience with pharmaceuticals or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) is valuable.


Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.