GEM Regulatory Leads - EAMEA

Takeda

Feb 9

Applications are closed

Job
Full-time
Senior Level
Dubai

Requirements

BSc. Advanced scientific related degree preferred; BA accepted based on experience.
A minimum of 8 years of experience in drug regulatory affairs preferably within the EU/GEM region.
Prior experience of ‘area’/ countries will be an advantage
Receives and gives feedback; expresses ideas, questions, and disagreement
Fluency in English and other local languages will be an advantage
Work in flexible hours

Responsibilities

Defines, develops, and leads area regulatory strategies, in close alignment with line management and Country (LOC) RA Heads, to maximize regulatory success and enabling patient access, including all aspects of submission and timely approval of investigational drugs, marketing authorizations and life-cycle management submissions and subsequent Q&As from authorities.
Effectively communicates (including Global Product Team (GPT) representation when relevant) the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of regulatory strategies and impact assessments of trends, regulations and changes related to assigned programs.
Liaise with cross functional stakeholders including Global Regulatory Teams (GRT) to represent GEM RA strategies
Additionally may act as GEM RA Lead for one or more assets for entire GEM region covering from development to the life cycle maintenance activities.
Provides strategic and tactical advice, guidance and area regulatory expertise to global leadership teams on how to achieve timely and efficient conduct of development and/or life-cycle management of assigned programs while maintaining full compliance with applicable regulatory requirements
Leads the Submission Working Group (SWG) for submissions in the area and represents the area as needed on global and project teams for the new Mas & other major submissions
Manages or supports and oversees interactions with Health Authorities in the Area in collaboration with Area stakeholders and LOC RA teams
May support value and access team in their interactions with Health Authorities for negotiations related to products within their responsibility (wherever applicable) – For specific areas only
Evaluates new business development opportunities and / or participates in due diligence teams
May act as Deputy of RA Area Head and may support RA activities for other areas as needed
Demonstrates Takeda leadership behaviors at all times
Independently manages, plans, and works closely with Regional, LOC Regulatory Leads, BU Cross-functional Teams (CFT), and Global Regulatory Teams to deliver all aspects of regulatory activities throughout the product life cycle in close partnership with Global Regulatory TA Leadership and aim for a successful and timely outcome of RA applications in the area
Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
Accountable for communications to the regulator, development teams, and GRA, other Research and Development (R&D) functions, and TAU leadership.
Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management.
Participates, as appropriate, and authors/reviews internal procedures and processes.
Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, cross- functional commercial Area & LOC Teams; company’s consultants and Business Partners as required.
Actively pursues or oversees the tracking and fulfillment of post- marketing commitments.
Presents regional regulatory strategies to leadership/senior management and shall be able to identify and share the risks and opportunities as well as probability of success of proposed strategy

FAQs

What is the primary role of GEM Regulatory Leads in EAMEA?

The primary role of GEM Regulatory Leads is to define, develop, and lead regulatory strategies to maximize regulatory success and enable patient access, overseeing all aspects of submissions and approvals for investigational drugs and marketing authorizations.

How many years of experience in drug regulatory affairs is preferred for this position?

A minimum of 8 years of experience in drug regulatory affairs, preferably within the EU/GEM region, is required for this position.

What educational qualification is preferred for candidates applying to this role?

A BSc in an advanced scientific-related degree is preferred, although a BA may be accepted based on experience.

Is fluency in languages other than English advantageous for this role?

Yes, fluency in English and other local languages is considered an advantage.

What are some key responsibilities of the GEM Regulatory Leads?

Key responsibilities include leading regulatory submissions, liaising with cross-functional stakeholders, managing interactions with health authorities, and providing strategic advice to global leadership teams.

Where is this position located?

This position is located in Dubai, UAE.

What type of work schedule is expected for this role?

The position is full-time and may require working flexible hours.

Will the GEM Regulatory Lead have a role in market access negotiations?

Yes, the role may involve supporting the value and access team in their interactions with health authorities for negotiations related to products.

Do candidates need to have prior experience in specific therapeutic areas?

Experience with advanced therapeutic medical products, such as cell and gene therapy, will be advantageous for candidates applying to this role.

What kind of leadership skills are expected from GEM Regulatory Leads?

Candidates should demonstrate leadership behaviors, the ability to manage regulatory procedures independently, and foster an inclusive culture while actively promoting open dialogue and feedback.

Takeda

Better Health, Brighter Future

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.