Posted to MedZilla on 9/23/2017


Takeda Pharmaceuticals

US-MA, Manager, Global Regulatory Affairs Development 1700926-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr. Manager/Manager, Global Regulatory Affairs Development in ourCambridge MAoffice.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Manager/Manager, Global Regulatory Affairs Developmentworking on theGlobal Regulatory Affairsteam, you will be empowered toinnovative andcollaborative, and a typical day will include:


POSITION OBJECTIVES:
  • The Regulatory Affairs Manager will plan, manage and execute all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility with regards to compliance to Competent Authority regulations. This may include activities associated Contract Research Organizations (CROs) This person will help ensure that all documents for regulatory applications are prepared in accordance with company SOPs, GCP and other guidelines. This position requires that there is participation on project teams, providing regulatory support in the areas of clinical, non-clinical, Chemistry, Manufacturing and Controls (CMC) and other related areas.
  • Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
  • Serves as regulatory lead on the global development team (CTWG) for individual project of responsibility. Can have multiple projects depending on development stage and complexity.
  • Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.

ACCOUNTABILITIES:

  • Working with global lead (GRL and GSM) as needed in leading the regulatory working team (SWG) and represents regulatory at CTWG; ensures global regulatory strategy is written and executed according to plan for assigned projects.
  • Manage all relevant submissions and approvals for project(s) of responsibility.
  • Accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
  • Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
  • For the project(s) of responsibility, collaborates with global and other regional counterparts ensuring critical deliverables to territories are provided outside of region to ensure regional execution of the strategy as agreed within the global regulatory strategy
  • Keeps Medical, CMC and Regulatory Affairs employees abreast of changes to regulations and the impact on corresponding procedures.
  • May develop/author for less complex programs or assist Global Regulatory Lead with development of global regulatory strategy.
  • Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
  • Generally serves as regulatory lead on the global development team (CTWG) for individual project(s) of responsibility. Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
  • Generally the primary regulatory authority contact for project(s) of responsibility.
  • Direct point of contact with health authorities on general issues.
  • Manages & executes day-to-day activities for projects.
  • Assists and attends regulatory authority and other agency meetings and can lead with oversight.
  • Identifies and notifies management of resource gaps for assigned project(s), when necessary.
  • Ensure regulatory compliance of marketed products.
  • May manage associate level regulatory personnel.
  • As assigned, is responsible for due diligence activities for evaluation of possible in-licensing compounds in area of therapeutic responsibility
  • As assigned, is responsible for regulatory evaluation portion of feasibility assessments of pipeline candidates.
  • Other ad-hoc duties as required.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc Degree, preferred. BA accepted.
  • Moderate pharmaceutical industry experience. This is inclusive of reasonable regulatory experience or combination of moderate regulatory and/or related experience.
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
  • Experience as primary liaison to regulatory authorities and in handling Agency meetings
  • Basic working knowledge of drug development process and regulatory requirements.
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
  • Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Must work well with others and within global teams.
  • Able to bring working teams together for common objectives.
  • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Drug Development - understands the phases, processes and techniques used within a drug development environment including protocol design and development.
  • Understands appropriate Competent Authority regulations and guidelines.
  • Good Clinical Practices (GCP) understands good clinical practices and can apply to a research environment.
  • Working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to a pharmaceutical research and production environment.
  • Applicable regulations, guidelines and regulatory processes
  • Demonstrates problem-solving and interpersonal skills through effective interactions with team members and generates alternative solutions prior to elevation of issues to manager.
  • Knowledge of team dynamics and ability to function as team leader.
  • Ability to function with a good level of independence.
  • Technical Leadership skills/understanding of managing people.
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:

Requires approximately 20% travel

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule


Please visit our website at takedajobs.com

 
 


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