Regulatory Affairs & Scientific Office Manager KSA

Bayer

Riyadh Region, KSA

Full-time

Mid-Senior

Onsite

Discovered 1 weeks ago

Regulatory affairsScientific office managementNational regulatory requirementsMarketing authorization proceduresRegulatory strategyProduct-related issue and risk management

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Key skills for this role

Regulatory affairsScientific office managementNational regulatory requirements

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Company Context

Bayer describes itself as a purpose-driven healthcare company focused on solving major health and nutrition challenges.

The company describes a digital-first culture and promotes development programs and professional growth opportunities.

Role Overview

The Scientific Office and Regulatory Manager represents Bayer Consumer Health as a partner to authorities and stakeholders on regulatory and scientific matters.

The role serves as a company contact person and representative for regulatory and scientific matters in Saudi Arabia.

The role is part of the cluster Consumer Health Regulatory team and local Consumer Health management team.

Regulatory Leadership

Manage the local portfolio, including new and existing marketing authorizations in Saudi Arabia.
Provide guidance on regulatory strategy, processes, issues, and risks to local, regional, and global business functions.
Drive regulatory activities in line with local and regional strategy, consumer centricity, innovation, and regulatory excellence.
Implement regulatory strategy tailored to the specific needs of Saudi Arabia.
Support product-related issue and risk management activities.

External Stakeholder Management

Build regulatory networks and maintain professional relationships with national regulators, local industry organizations, and key opinion leaders.
Coordinate with the Commercial Lead on public policy goals and improving recognition of self-care by government authorities.
Lead the scientific office in Saudi Arabia and act as a liaison between business and governmental parties.
Review the external regulatory environment and communicate relevant business impacts internally.
Keep up to date with local and global codes, regulations, and laws.
May represent Bayer on local trade association regulatory committees.

Experience

Scientific degree, such as a PhD or PharmD, or equivalent.
Knowledge of national regulatory requirements and at least five years of experience managing national registration procedures.
Business insight to apply marketplace focus when prioritizing actions and aligning goals with business growth.
Ability to build collaborative stakeholder relationships and drive project delivery.
Strong customer focus and ability to maintain long-term relationships with key authorities.
Ability to manage ambiguity and work in a changing environment.