Associate Director, Regulatory Affairs

Job Description

The Position

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.

Secondary Job Description

Note: There will be an outbound CV screening interview call from our Talent Attraction Business Partner , and the call may come from an overseas number .

Please make sure to answer the international call to proceed with your application.

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.

Search Firm Representatives Please Read Carefully 

Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

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