Regulatory Affairs Specialist

By clicking the "Apply" button, I understand that my employment application
process with Takeda will commence and that the information I provide in my
application will be processed in line with Takeda's Privacy Notice and Terms
of Use. I further attest that all information I submit in my employment
application is true to the best of my knowledge.

Job Description

Job Purpose
Responsible for the regulatory affairs procedures for Saudi Arabia and
assigned therapeutic area.
Primary duties
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.
Develop effective relationships with local commercial organization,
distributors and service providers if needed
Ensure compliance with local regulation as part of Responsible pharmacist
duties in front of KSA authorities
Provide regulatory guidance and advice on local country regulatory
environments.
Provide assessment of the impact of new and changing regulations/requirements
in KSA countries
Use external resources to assist with the above tasks to not only meet
timelines but expediting the time to market.
Responsibilities

Regulatory Affairs:
% of Time/ Job Function and Description
* ‎60%
In collaboration with Global RA, provide regulatory strategies to responsible
functional groups and regulatory management.
Prepare and submit Takeda 's market applications, variations, Renewal, post
approval reporting obligations and general product life cycle management
support for KSA
Prepare and maintain project plans and timelines of approvals and planned
submissions.
Ensure that Takeda's products comply with the registration of health
authorities in KSA
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.
Ensure appropriate evaluation of local business and regulatory registration
requirements for investigational and marketed products and prepare regulatory
assessment reports as needed.
Interact with 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
* ‎20%
Ensure compliance of regulatory activities in Saudi Arabia consistent with
Country laws and Takeda's internal protocols and procedures
Ensure compliance with Saudi FDA local regulation
Ensure regional regulatory documents, record keeping in secure, comprehensive
manner
Ensure that all local product information used locally are up to date
* ‎10%
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 in the KSA
* ‎10%
Support the RA Head the ME on specific projects as requested in alignment with
RA Lead Saudi Arabia.
Major Challenges
* To comply with different requirements of products registration in Saudi Arabia.
* Ensure uniformity and alignment of cluster/regional strategies, processes, and policies.
* Proper utilization of resources to effectively implement the registration strategies.
Key Decisions Expected
* Finalization of new products registration as per plan
* Execution of KSA Regulatory affairs strategies to achieve business objectives
* External interface with health authorities and Takeda distributors
* Day to day operational decisions
Dimensions
* Geographical span: Saudi Arabia
Skills & knowledge
Educational qualifications
BA in related field from a renowned institution / university Saudi National &
Pharmacist
Relevant Experience & knowledge
* ‎4-‎5 years of total experience
* ‎3+ years of solid Regulatory affairs experience in a medium to large size reputable organization/s in Saudi Arabia
* Good in-depth knowledge of key business functions such as Sales, business development, marketing, Medical, etc.
* In-depth understanding of pharmaceutical industry within the country
* Applicant must be a Saudi National
Personal Characteristics & behaviors
* 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 verbal and written communication skills
* Goal oriented, focused, energetic, and enthusiastic
* IT savvy and process orientation
* Excellent team work and collaboration

Locations

Riyadh, Saudi Arabia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time