Regulatory Affairs Senior Manager

P&G - الإمارات - دبي

توظيف: دوام كامل

p style=\"text-align:left\">Job Location

Dubai

Job Description

Job Description Template

Overview of the job

You will be a key driver behind our continued growth and success. With our commitment to innovation, you will seek out, develop, and help implement strategic initiatives for improved efficiency and productivity. From creating regulatory affairs strategies to executing product submissions and registrations across the Middle East and Africa, you need to be a detailed planner, excellent communicator, and expert in regulatory affairs. You will be dedicated to ensuring regulatory compliance and facilitating market access for our products, navigating complex regulatory landscapes with precision and expertise.

Your team

This role reports to Director of Regulatory Affairs Middle East & Africa & will look after Middle East & North Africa countries.

How Success Looks Like

You understand regulatory requirements deeply and apply them effectively to ensure compliance across the Middle East and Africa markets.
You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access and minimal delays.
You build and maintain strong relationships with regulatory authorities, leveraging these connections to facilitate approvals and address any challenges.
You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.
You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.
You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.
You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.

Responsibilities of the role

Work autonomously, but in alignment with local manager, to coordinate day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
Understands the regulatory landscape across Middle East , Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest.
Handles compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are in place and adhered to.
Handles the coordination, compilation and submission of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements.
Works with substantial discretion and uses best practices and knowledge of internal or external business issues to improve products or services.
Uses specialist knowledge, analytical skills, judgment, and broad conceptual and practical experience to solve complex problems and to contribute to process improvements.
Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.

Core Regulatory Practices:

To prepare & submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.
To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.
To ensure the renewal of registration of products by defining the accurate timelines.
To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards
To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.
To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.
To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.
Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management
Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.
Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

Role Requirements

Qualifications & technical skills

A minimum of a bachelor’s degree in pharmacy, or medical degree
Years of Experience: 10 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience
Language: Arabic/English
Location: Dubai /UAE

Soft skills

Experience from a multi-national or regional company is required.
Experience in Pharma & Consumer Healthcare products
In depth knowledge of Middle east, North Africa, and European legislation.
Excellent Oral & written communication skills
Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result

About us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.

Visit http://www.pg.com to know more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.

Job Qualifications

Qualifications & technical skills

A minimum of a bachelor’s degree in pharmacy, or medical degree
Years of Experience: 10 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience
Language: Arabic/English
Location: Dubai /UAE

Job Schedule

Full time

Job Number

R000106782

Job Segmentation

Experienced Professionals (Job Segmentation)

قدم على موقع الوظيفة

تاريخ النشر: اليوم

الناشر:

Regulatory Affairs Senior Manager

Overview of the job

Your team

This role reports to Director of Regulatory Affairs Middle East & Africa & will look after Middle East & North Africa countries.

How Success Looks Like

You understand regulatory requirements deeply and apply them effectively to ensure compliance across the Middle East and Africa markets.

You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access and minimal delays.

You build and maintain strong relationships with regulatory authorities, leveraging these connections to facilitate approvals and address any challenges.

You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.

You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.

You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.

You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.

Responsibilities of the role

Work autonomously, but in alignment with local manager, to coordinate day-to-day Regulatory Affairs activities for specific area(s) of responsibility.

Understands the regulatory landscape across Middle East , Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest.

Handles compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are in place and adhered to.

Handles the coordination, compilation and submission of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements.

Works with substantial discretion and uses best practices and knowledge of internal or external business issues to improve products or services.

Uses specialist knowledge, analytical skills, judgment, and broad conceptual and practical experience to solve complex problems and to contribute to process improvements.

Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.

Core Regulatory Practices:

To prepare & submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.

To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.

To ensure the renewal of registration of products by defining the accurate timelines.

To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards

To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.

To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.

To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.

Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management

Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.

Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

Role Requirements

Qualifications & technical skills

A minimum of a bachelor’s degree in pharmacy, or medical degree

Years of Experience: 10 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience

Language: Arabic/English

Location: Dubai /UAE

Soft skills

Experience from a multi-national or regional company is required.

Experience in Pharma & Consumer Healthcare products

In depth knowledge of Middle east, North Africa, and European legislation.

Excellent Oral & written communication skills

Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result

About us

Visit http://www.pg.com to know more.

Qualifications & technical skills

A minimum of a bachelor’s degree in pharmacy, or medical degree

Years of Experience: 10 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience

Language: Arabic/English

Location: Dubai /UAE