Regulatory Affairs Lead – East Gulf and Levant

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Job Description

Job Title:  Regulatory Affairs Lead – East Gulf and Levant

Location:  Dubai, UAE

About the role: 

• Responsible for the regulatory affairs procedures & strategies for assigned territory East Gulf and Levant Countries (UAE, Kuwait, Lebanon, Iran, Iraq & Libya)
• Lead for RA LOC team in East gulf and Levant region.

How you will contribute: 

• Effective Team lead for East Gulf and Levant RA team as well managing external RA contractor for assigned project in order to meet expected RA timelines and KPIs.
• Responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business to enable ultimate strategy and faster access to innovative medicines in the region.
• Develop effective relationships with local commercial organization, distributors cross functional team and service providers if needed in the region.
• Ensure compliance with local regulations as part of duties in front of East Gulf & Levant health authorities through local distributor.
• Ensure product regulatory assessment to be done for each product respective changes and/or variations as per local applicable health authorities’ regulations and relevant Takeda standards in the respective Takeda system.
• Provide regulatory guidance and advice on local country regulatory environments to region and global regulatory teams.
• Provide assessment of the impact of new and changing regulations/requirements in East Gulf and Levant countries.
• Work efficiently and in close collaboration with different CFT GxP (QA, PV) and non GxP functions (Finance, legal.)
• Review of promotional material of assigned TA in East Gulf and Levant.
• Review and provide an input RA opex in East Gulf and Levant countries in alignment with General manager and GEM Regulatory Area EAMEA
• Support area as well GEM RA team for specific projects when required.

Regulatory Affairs: 60% of Time

• In collaboration with GEM RA area head at EAMEA & in alignment with GEM RA team & IRS PDT Team, provide regulatory strategies to responsible functional groups and regulatory management.
• Ensure & support RA team to prepare and submit Takeda’s market new applications, variations, post approval reporting obligations and general product life cycle management support for the applicable countries in East Gulf & Levant countries as agreed plan with regional & global regulatory timelines
• Prepare and maintain project plans and timelines of approvals and planned submissions.
• Ensure RA team comply with the registration of health authorities in the region for all registered products for the assigned countries.
• Prepare (as needed) and review key application components and meeting materials and chair/attend meetings with regulatory agencies and participate in agency inspections as required.
• Support different CFT team for successful internal audit
• Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.
• Interact with local distributors; service providers and regulatory agencies to resolve related review questions
• Act as a point of contact for the assigned projects and as interface with key corporate functional areas

Regulatory Affairs: 20% of Time

• Team leads to ensure effective achievements of the following:
• Ensure compliance of regulatory activities in East Gulf and Levant countries consistent with Country laws and Takeda’s internal protocols and procedures (CMLR, Labelling compliance, etc) in coordination and liaison with GRA labelling and Ad/Prom Groups with support of RA LOC team
• Review and approve all promotional material in the region and ensure MOH approval in respective countries where required.
• Ensure compliance with East Gulf and Levant countries local regulation as part of Responsible pharmacist duties in front of MOH.
• Ensure regional regulatory documents, record keeping in secure, comprehensive manner
• Ensure that all local product information used locally are up to date
• Ensure the quarterly review of the annex H in the PSMF as by entire RA LOC team
• Ensure all safety variations submissions as per the global timelines for the registered products to the health authorities as aligned with LOC RA team
• Budget review and consolidation with East Gulf and Levant LOC

Regulatory Affairs: 10% of Time

• Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements
• Develop effective working relationships with business partners and service providers with commercial and franchise head for East Gulf and Levant countries, including local visits to Key HA within GCC countries as needed.
• Continue Development of RA Team in East Gulf and Levant

Regulatory Affairs: 10% of Time

• Support the RA regional and GEM RA team on specific projects as requested.

Core Elements Related To This Role:

• Regulatory compliance: Ensuring all activities, processes, products comply with relevant regulations and laws.
• Regulatory submissions: Preparing, compiling and submitting regulatory documents such as new drug applications, renewals and variations.
• Labelling and packaging compliance; Ensuring that product labelling and packaging meet regulatory requirements.
• Quality Assurance: collaborating with QA team to ensure the products meet quality standards.
• Cross Functional Collaboration; collaborating with various departments at LOC and Global side to ensure smooth regulatory plan execution.
• Communication with distributors and health authorities by responding to inquiries, providing information when requested and follows up on the ongoing projects.

Key Decisions Expected

• Propose optimal RA strategy and ensure efficient Execution in East Gulf and Levant countries Regulatory affairs projects and operations to achieve business objectives
• External interface with health authorities and Takeda distributors
• Day to day operational decisions
• As a Team leader, should be able to continue leading efficiently and with excellence

Dimensions And Aspects:

Technical/Functional (Line) Expertise

• Fully aware of the technical part of the CTD submissions and how to translate the regulations into workable plan to ensure smooth files preparation as per the regulations.

Leadership

• Strong communication skills to effectively convey ideas, provide guidance when needed

Decision-making and Autonomy

• Strong critical thinking skills to evaluate information and make decisions

Interaction

• Collaboration: ability to work effectively with others, build relationships and have team spirit.
• Active listener: ability to listen attentively, understands other perspectives and communicate effectively.

Innovation

• Creativity: ability to think out of the box, generate new ideas and propose solutions to challenges
• Problem solving skills; ability to identify problems, analyze root cause and develop creative solutions

Complexity

• Adaptability; ability to adapt to changing structures and responsibilities and environments.
• System thinking; capacity to understand complex systems
• Resilience: ability to bounce back from setbacks, learn from failures

What you bring to Takeda: 

Educational Qualifications

• BA in scientific medical background

Relevant Experience & Knowledge

• 7-8 years of total experience with extensive GCC experience, other international regulatory experience is preferable
• 5 years of extensive & solid Regulatory affairs experience in GCC countries in a medium to large size reputable organization/s for pharmaceutical products,
• In-depth understanding of regulation in the GCC countries

Personal Characteristics & Behaviours

• Strategic thinker, innovative, able to drive multiple simultaneous initiatives, able to work under pressure
• Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
• Excellent leadership, managerial, interpersonal and relationship building skills
• Excellent verbal and written communication skills
• Goal-oriented, focused, energetic, and enthusiastic
• IT savvy and process orientation

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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