Associate Director, Regulatory Affairs

Organon LLC; Kuala Lumpur; Sur place; MYR 300 000 - 540 000; Plein temps

Résumé du poste

Organon is seeking an Assoc. Director to lead regulatory and pharmacovigilance efforts in Malaysia. The role combines scientific insight with regulatory acumen to ensure compliant product registration, post-marketing lifecycle management, and effective oversight across markets.

You will manage a team, collaborate with cross-functional partners, and drive registration strategies integrated into business plans. English fluency is essential, and pharmacist credentials are highly valued.

Qualifications

• 8–10 years of industry experience in pharmacovigilance and/or regulatory affairs.
• Pharmacist license is required.
• Fluent in English (written and spoken); local language skills preferred.

Responsabilités

• Develops product registration plans & strategies in accordance with local regulations and global standards.
• Identifies and manages risks and business needs across markets.
• Supports development and implementation of leading-edge systems and simplify practices internally across functions.
• Drives regulatory compliance and quality; prepares for audits/inspections for the assigned market(s).
• Liaises with local business units to inform regulatory trends and strategic decisions.

Connaissances

Regulatory affairs

Pharmacovigilance

Leadership

English fluency

Formation

Pharmacist license

Bachelor's degree in Health Sciences

Description du poste

Job Description

The Assoc. Director is responsible for all aspects of regulatory and pharmacovigilance responsibilities in Malaysia. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable new products that are developed, manufactured, or distributed in compliance with the local legislations. This role is responsible for managing post-marketing Lifecycle Management (LCM) activities (e.g. change management, line extension, re-registrations, claims, labeling support) and external regulatory surveillance. This role reports to AP Cluster Regulatory Lead and manages direct reports within the assigned market. She/he will be a member of local leadership team, drives innovation and ensures that product registration strategies, preparation/submission of marketing approval applications are well integrated into the business plans.

Responsibilities

• Develops product registration plans & strategies in accordance with local regulations and global standards, working cross-functionally to review & communicate the registration strategy with management oversight.
• Identifies and manages risks and business needs.
• Supports development and implementation of leading-edge systems and simplify practices internally/ across functions.
• Identify and implement new regulatory policies, SOPs, as appropriate.
• Provides regulatory expertise in the planning, execution, and maintenance of major projects that have high impact to the business.
• Represents RA in cross-functional organizational and alliance partner forums, support due diligence activities and execute respective agreements as needed.
• Serves as local Subject Matter Expert on relevant regulatory processes.
• Participate on local company committees and councils (as appropriate) for matters impacting regulatory compliance.
• Drives regulatory compliance and quality, prepares for audits/inspections for the assigned market(s) and actively participates in the audit and/or inspection including audits of contractual partners/vendors as necessary.
• Liaises with the local business units to keep them apprised of regulatory trends and provide input on strategic decisions (i.e., new clinical trials, product launches, and related activities).
• Coordinates the filing, storage and archiving of regulatory data and documentation in accordance with company’s policies and local requirements Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business.

Competencies

Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Demonstrates advanced skills to drive change and champions development. Delivers with accountability: Aligns strategic priorities to team priorities and team resources and delivers results in accordance with timelines and appropriate regulations. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes. Innovates with agility: Encourages diverse thinking and experiments with new ways of working. Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks. Communicates with optimism and authenticity: Articulates a compelling shared vision and communicates with empathy. Makes timely and appropriate decisions and to determine when escalation of issues is necessary. Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams.

Required Education, Experience and Skills

Minimum of 8 - 10 years of industry experience in pharmacovigilance and/or regulatory affairs. Pharmacist license is required. Supervisory experience in managing people/teams/contractors across markets is highly preferred. Expert knowledge, understanding, and application of principles, concepts, and practice of regulations across Asean markets. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio. The incumbent must have a University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent by education / experience and fluent in English (written and spoken) while proficient in local language. Local registered pharmacist is highly preferred.

Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

Job Details

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10% Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1