Regulatory Affairs TSO Manager KSA

ARA-P3-12

The Role

• Accountable for the regulatory affairs in Saudi. Drive optimal regulatory outcomes and ensure governance on regulatory activities. Support PV Operations leadership as needed.
• Act as TSO manager in KSA on behalf of the company.

KEY RESPONSIBILITIES

• Ensure full compliance to all local and international regulations, codes and standards and company SOP.
• Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives.
• Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.
• Ensure filing strategy is aligned with global strategy.
• Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
• Ensure maintenance of appropriate systems for Regulatory activities and documentation.
• Ensure regulatory budget is prepared and maintained and aligned with global budget requirements.
• Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate.
• Ensure validity of Scientific Office licenses based on Local HA regulations.
• Respond to authorities’ inquiries related to Scientific Office.

KEY SKILLS

• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
• Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources.
• Strong initiation and organization skills
• Outstanding written and oral communication and negotiation skills.
• Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities
• Good technical skills in the local HA online submission system or equivalent systems

QUALIFICATIONS

• Educational Qualifications:
  • Bachelor’s degree or equivalent or higher, in Pharmacy
  • Saudi National with a Pharmacist license from the Saudi Council of Health Specialities
• Relevant Experience:
  • Candidates must have at least 5 years’ experience in regulatory affairs dealing with a wide variety of registration projects and issues.
  • Candidate should have experience in dealing with Pharmacovigilance matters.

 

Additional Job Description:

Primary Location:

SA Riyadh

Job Posting Date:

2025-08-13

Job Type:

Permanent