Specialist, Regulatory Affairs

Organon; Kuala Lumpur; Hybrid; MYR 60,000 - 90,000; Full time

Job summary

Organon Malaysia seeks a Regulatory Affairs Specialist to manage regulatory submissions for local products, ensure lifecycle management, and collaborate with cross-functional teams to meet local regulatory requirements.

You will prepare MAAs, variations, renewals, and post-market dossiers, while maintaining regulatory data and supporting audits and readiness activities. A local pharmacist with a health-sciences degree is required.

Qualifications

• Minimum of 2 to 5 years of industry experience in regulatory affairs in Local or MNC pharmaceutical company.
• University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent.
• Local registered pharmacist is required.

Responsibilities

• Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
• Timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• Archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements including licenses, import and distribution of pharmaceuticals and medical devices.
• Ensure compliance with global and local SOPs and report deviations or compliance concerns; assist in corrective actions locally.
• Support local audits, inspections and readiness activities including audits of contractual partners/vendors and response to findings/observations.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with stakeholders.

Skills

Regulatory affairs

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Health Sciences or equivalent

Local registered pharmacist

Job description

The Specialist is responsible for all aspects of regulatory submissions Malaysia. Critical to this role is to combine knowledge of scientific and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Managing post-marketing Lifecycle Management (LCM) activities (e.g. change management, line extension, re-registrations, claims, labeling support) and external regulatory surveillance. Leveraging on expertise in local regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity. The Specialist reports to Country Regulatory lead and may act as the regulatory relevant License Holder for the company.

Responsibilities

• Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
• Timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• Archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements including, but not limited to, product licenses, import and distribution of pharmaceuticals and medical devices.
• Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
• Support local audits, inspections and readiness activities including audits of contractual partners/ vendors and response to findings/observations.
• Assists in developing local procedures (in compliance with regional and global standards) for the department and evaluate processes for potential improvement in efficiency and effectiveness.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with local Quality and Supply Chain to avoid supply constraints.
• Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed.
• Delivers with accountability: 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 to respond to new, complex, or problematic situations.
• 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: Demonstrates good oral and written communications and presentation skills. 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 2 to 5 years of industry experience in regulatory affairs in Local or MNC pharmaceutical company
• The incumbent must have a University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent.
• Local registered pharmacist is required.
• He/she must have a sound knowledge of regulations within the assigned markets and be an expert in local regulatory processes and activities.
  

Secondary Job Description

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

Job Description

The Position

The Specialist is responsible for all aspects of regulatory submissions Malaysia. Critical to this role is to combine knowledge of scientific and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Managing post-marketing Lifecycle Management (LCM) activities (e.g. change management, line extension, re-registrations, claims, labeling support) and external regulatory surveillance. Leveraging on expertise in local regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity. The Specialist reports to Country Regulatory lead and may act as the regulatory relevant License Holder for the company.

Responsibilities

• Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
• Timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• Archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements including, but not limited to, product licenses, import and distribution of pharmaceuticals and medical devices.
• Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
• Support local audits, inspections and readiness activities including audits of contractual partners/ vendors and response to findings/observations.
• Assists in developing local procedures (in compliance with regional and global standards) for the department and evaluate processes for potential improvement in efficiency and effectiveness.
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with local Quality and Supply Chain to avoid supply constraints.

Competencies

• Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed.
• Delivers with accountability: 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 to respond to new, complex, or problematic situations.
• 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: Demonstrates good oral and written communications and presentation skills. 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 2 to 5 years of industry experience in regulatory affairs in Local or MNC pharmaceutical company
• The incumbent must have a University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent.
• Local registered pharmacist is required.
• He/she must have a sound knowledge of regulations within the assigned markets and be an expert in local regulatory processes and activities.
  

Secondary Job Description

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:

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

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Pharmaceuticals, Biotechnology & Medical Devices 5,001-10,000 employees

Organon is an independent global healthcare company with a strategy to improve the health of women throughout their lives. Our diverse portfolio across women's health, biosimilars, and established brands includes therapies and products for a wide range of conditions and diseases.

Our portfolio encompasses more than 70 medicines and products across a range of areas including reproductive health, cardiovascular disease, neurology, dermatology, autoimmune, and respiratory conditions. We bring these important therapies to more than 140 markets around the world.

We are here for her health.

Organon is an independent global healthcare company with a strategy to improve the health of women throughout their lives. Our diverse portfolio across women's health, biosimilars, and established brands includes therapies and products for a wide range of conditions and diseases.

Our portfolio encompasses more than 70 medicines and products across a range of areas including reproductive health, cardiovascular disease, neurology, dermatology, autoimmune, and respiratory conditions. We bring these important therapies to more than 140 markets around the world.

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