Regulatory Affairs Senior Manager, GRA, RPR MEA, Riyadh, KSA

This job is OPEN to APPLY for ALL Nationalities, unless otherwise specified.

We need a Regulatory Affairs Senior Manager,

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Global & Regional Regulatory Affairs

Job Type: Full Time

Location: Riyadh, Riyadh, Saudi Arabia

Employer Reference: R-266747

Job Description

Main Responsibilities and Accountabilities

1. Strategic Focus

Lead the development and execution of regulatory strategies for complex projects across KSA and MEA partner markets:
Assess regulatory pathways and identify optimal submission strategies to accelerate approvals while ensuring compliance with local and global requirements.
Anticipate regulatory challenges and proactively design mitigation plans to minimize risks and delays.
Align regulatory strategies with business objectives, product lifecycle plans, and commercial priorities to support timely market access.
Collaborate with cross-functional teams (clinical, quality, manufacturing, commercial) to integrate regulatory considerations into project planning and decision-making.
Drive innovative approaches to meet evolving regulatory requirements and leverage regional insights to influence global strategy.

Ensure oversight on key processes and frameworks to manage third-party activities end-to-end, ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance, and address deviations promptly.

2. Technical Regulatory Responsibilities for KSA (in Coordination with Scientific Office Manager)

Responsible for technical regulatory activities in KSA, while coordinating all actions with the Scientific Office Manager for the TSO in Saudi, including:

Performing regulatory assessments for new products and variations.
Preparing and compiling complete regulatory dossiers in alignment with SFDA requirements.
Managing electronic submissions through the SDR portal via the Scientific Office in KSA.
Responding to SFDA queries and deficiency letters promptly and effectively.
Ensuring compliance with all local regulatory standards and timelines for approvals.
Maintaining proactive communication with SFDA to facilitate smooth review processes.

Also responsible for interaction with distributors and local partners for local manufacturing projects in KSA to ensure all regulatory activities are on track and aligned with compliance requirements.

3. Regulatory Oversight for Partner Markets in MEA (Assigned Markets)

Manage distributors and partners in assigned Partner Business markets.
Prepare regulatory dossiers and provide regulatory assessments for these markets, ensuring compliance with local requirements and company standards.
Ensure distributors submit dossiers to Health Authorities on time and in full compliance with regulatory requirements.
Conduct audits and assessments to ensure compliance with local requirements and quality standards; implement corrective actions and risk mitigation strategies.
Act as RA representative in audits/inspections and ensure readiness and timely CAPA closure.
Serve as escalation point for partner-related issues and align closely with GRA for contract management.

4. Regulatory Intelligence & Authority Interaction

Stay updated on regulatory requirements, guidelines, and industry trends; communicate changes to GRA and local teams.
Communicate with Health Authorities, specifically SFDA, for all regulatory activities as needed, while ensuring coordination with the Scientific Office Manager.

5. Submission Management

Support regional regulatory teams in planning and submission preparation according to local requirements.
Perform preparation and submission of regulatory dossiers, including variations, labeling, and NDAs, ensuring compliance with local regulations.
Demonstrate strong knowledge of eCTD structure and requirements, including publishing tools (e.g., DocuBridge), eCTD compilation, and technical validation.
Ensure familiarity with electronic submission processes through SDR in in Saudi Arabia ; maintain awareness of all technical aspects related to electronic submissions.

6. Systems & Data Integrity

Maintain accurate and timely updates in regulatory systems and databases such as Veeva Vault RIM.
Demonstrate advanced experience in Veeva, including:

Managing end-to-end regulatory workflows within Veeva Vault RIM.
Uploading, organizing, and maintaining submission documents in compliance with global and local standards.
Ensuring data integrity and version control for all regulatory records.
Generating reports and dashboards to track submission status and compliance KPIs.
Coordinating with global teams to ensure alignment of Veeva processes across regions.

7. Labeling Responsibilities

Experience in end-to-end labeling processes, including country-specific labels and multi-country shared labels.
Ensure compliance with local GCC labeling requirements.
Coordinate labeling activities with other team members for MEA shared labels to ensure timely updates and consistency.
Demonstrate knowledge of GLAMS labeling process and maintain accurate labeling records in the system.

8. Local Manufacturing Projects

Manage local manufacturing partners in KSA to ensure they are updated with the latest technical dossier of the product.
Ensure partners perform regulatory activities on time, including variations, labeling updates, and registration renewals.
Be actively involved in any new initiatives for local manufacturing in KSA and other MEA markets, providing regulatory guidance and support from planning through execution.

9. Stakeholder Management & Training

Act as primary interface with local partners in assigned markets, representing the company’s regulatory interests and fostering strong relationships.
Align with commercial in Partner Business Markets to ensure timely and standardized delivery of partner-specific activities.
Monitor training effectiveness and compliance; ensure proper training programs are developed and implemented.
Lead and deliver complex regional strategies across CSL products, ensuring alignment with company and commercial objectives.
Provide guidance for regulatory activities across MEA countries, adapting strategies to local requirements.

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Position Qualifications and Experience Requirements

Education

Bachelor’s degree in pharmacy, life sciences, or related field.
Certifications in quality or vendor management (e.g., CQA, CMQ, CSQP) desirable.

Experience

Minimum 10+ years in regulatory affairs within pharmaceutical, biotechnology, or healthcare industry.
Proven ability to develop and execute regulatory strategies for complex projects.
Strong experience in communication and negotiation with Health Authorities, specifically SFDA.
Hands-on experience in regulatory dossier preparation (variations, labeling, NDAs).
Proficiency in regulatory systems and databases such as Veeva Vault RIM.
Expertise in eCTD structure, publishing tools (e.g., DocuBridge), and electronic submission processes.
Experience managing local manufacturing projects, particularly in KSA.
Regional regulatory experience across multiple MEA countries.
Demonstrated ability to work in a highly matrixed organization and establish successful cross-functional relationships.
Experience in Pharmacovigilance is desirable.

Competencies

Fluent in Arabic and English (oral and written).
Advanced MS Office skills.
Strong organizational, time management, and interpersonal skills in a global environment.
Ability to work independently and collaboratively, with strong problem-solving and decision-making skills.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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