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Associate Director, Global Regulatory Affairs Development

Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: September 17, 2020

Job Description:

Associate Director, Global Regulatory Affairs Development - GI Company: Takeda Pharmaceuticals International GmbH

Location: Cambridge

Posted on: September 12, 2020

Job Description:

The health and safety of our employees and candidates is veryimportant to us. Due to the current situation related to theCoronavirus (COVID-19), we’re leveraging our digital capabilitiesto ensure we can continue to recruit top talent at Takeda. As yourapplication progresses, you may be asked to use one of our digitaltools to help you through your recruitment journey. If so, one ofour colleagues will explain how these tools will be used during therecruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targetingindividuals seeking jobs with Takeda and other employers. See belowor here for more info.

Associate Director, Global Regulatory Affairs Development - GITakeda fosters a collaborative and stimulating work environmentfilled with opportunity and the chance to make a difference inpeople's lives. It is a workplace driven by integrity, one ofTakeda’s long-held values that extends to both the patients weserve and our employees who develop and deliver medicines. Acrossour company, Takeda employees bring together diverse strengths thattogether create a stronger whole.

As one of the world’s leading biopharmaceutical companies,Takeda is committed to bringing Better Health and a Brighter futureto people worldwide. We aspire to bring our leadership intranslating science into life-changing medicines to the next level,in our core focus areas; oncology, gastroenterology, neuroscience,rare diseases, plasma-derived therapies, and vaccines. The GreaterBoston Area is headquarters to many of our Global and US businessunits.

We are a passionate team doing important work that impactspatients’ lives. If you are driven to create better health and abrighter future, join us!

Success What makes a successful member of our team? Check outthe traits we’re looking for and see if you have the right mix.

Life at Takeda A Global Top Employer Recognized for our cultureand way of working, we’re one of only select companies to receiveTop Global Employer ® status for 2020.

Associate Director, Global Regulatory Affairs Development - GIJob ID R0022271 Date posted 08/14/2020 Location Cambridge,Massachusetts

Are you looking for a patient-focused company that will inspireyou and support your career? If so, be empowered to take charge ofyour future at Takeda. Join us as a Associate Director, GlobalRegulatory Affairs Development - GI in our Cambridge MAoffice.

Here, everyone matters and you will be a vital contributor toour inspiring, bold mission. As an Associate Director, GRADevelopment - GI working on the Global Regulatory Affairsteam, you will be empowered to be strategic and innovative,and a typical day will include:

POSITION OBJECTIVES:

Oversees as well as executed all regulatory activities ofmultiple projects including one highly complex project indevelopment and/or supports regulatory activities for assignedmarketed product(s) of responsibility.

Manages director reports to support scope of project work.

Provides a regulatory strategic focus on non-clinical andclinical aspects of drug development and associatedregulations.

Serves as global regulatory lead (GRL) on the global projectteam (GPT) for individual project(s) of responsibility or delegatesto staff with oversight

Collaborates with all Takeda regions to ensure a globalregulatory strategy is created and executed upon for all projectswithin area of responsibility.

Primary FDA contact for projects of responsibility or candelegate to staff with oversight.

ACCOUNTABILITIES:

Leads the global regulatory subteam (GRT) and represents team atGPT ensures global regulatory strategy written and executedaccording to plan – or oversees if delegated to staff.

Accountable for all US FDA submissions and approvals ofproject(s) of responsibility or oversees direct reportsresponsible.

Responsible for independently achieving all submissions levels,including major submissions (NDA/BLA/MAA); may oversee staff inachieving major submissions.

Accountable for ensuring all other regulatory submissions withinthe non-US “Americas” territories are submitted on schedule bylocal Takeda affiliates or development partners (eg, PRA orco-development partners) within project(s) of responsibility byensuring the regulatory deliverables are provided as outlined inthe global regulatory strategy.

Oversee multiple projects and manager individual projects.

For the project(s) of responsibility, collaborates with EUand/or other regional counterparts in the authoring of globalregulatory strategies and ensures critical deliverables toterritories outside the US to ensure regional execution of thestrategy as agreed within the global regulatory strategy

Develop/author and execute global regulatory strategies for morecomplex strategies. May oversee execution.

Executes day-to-day activities for projects or delegates tostaff with oversight.

Identifies regulatory requirements and provides regulatoryguidance, and expertise to global development team on the assignedproject(s) of responsibility.

Direct point of contact with health authorities, leads andmanages FDA/health authority interactions/meetings.

Lead and manage Agency meetings.

Lead regulatory reviewer in due diligence for licensingopportunities.

Identifies and proposes solutions to management for any resourcegaps for project responsibility.

Provides oversight to ensure regulatory compliance of marketedproducts.

Present to senior management as requested.

Usually includes supervision of one or more direct reports.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BSc Degree preferred. BA accepted.

Advanced Degree preferred

A minimum of 8 years of pharmaceutical industry experience. Thisis inclusive of 6 years of regulatory experience or combination of8 years regulatory and/or related experience.

Solid working knowledge of drug development process andregulatory requirements, knowledge of FDA, EU, Canada, ROW, andpost-marketing a plus.

Preferred experience in managing major regulatory filing(s); andsignificant contributor to regulatory and/or developmentstrategies

Understands and interprets complex scientific issues acrossmultiple projects as it relates to regulatory requirements andstrategy.

Generally strong in most and acceptable in all basic skill setssuch as oral and written communications, managing and adhering totimelines, negotiation skills, integrity and adaptability.

Generally strong in working well with others and within globalteams; and acceptable at communicating with senior leadership

Generally strong and independent skills in the area ofregulatory strategy such as understanding broad concepts withinregulatory affairs and implications across the organization andglobally; proactively identifies regulatory issues; offers creativesolutions and strategies, including risk mitigation strategies.

Generally strong leader who is effective manager and is able tobring working teams together for common objectives, peoplemanagement experience preferred.

TRAVEL REQUIREMENTS: .

Requires approximately 20 % travel.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement ContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and healthscreenings

Generous time off for vacation and the option to purchaseadditional vacation days

Check out where you could be

working if you apply.

Job Seekers: Protect yourself against identity theft Please beaware there are instances of identity thieves postingTakeda-branded jobs and posing as employees to steal personalinformation. They visit job-related websites and invite candidatesto online chats. During the chat, they press job seekers to providebank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. Allrights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Associate Director, Global Regulatory Affairs Development - GI, Other , Cambridge, Massachusetts

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