Specialist, Regulatory Affairs

1 week ago

Kuala Lumpur, Malaysia Organon Full time

**Responsibilities**:
The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products.

The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.

The Specialist is also responsible for other activities (as delegated/assigned by their manager) which may include but are not limited to: review of local PV and RA agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues, developing product registration plans and strategies.

The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language. He/she should have a minimum of 1 year of industry experience in in pharmacovigilance and/or regulatory affairs. He/she must have a general knowledge of PV/RA regulations within his/her assigned country and be an expert in PV & RA processes/activities. The Sr. Specialist is expected to have good communication and time management skills.

**Regulatory Affairs**:
Technical changes management Label updates (non safety, safety, HA Directives, etc) & artwork maintenance HA request, post-market sampling Inquiries by CMC, RAI OOS notification to HA Renewal (internal preparation and external submission) Maintenance of product dossier/ folder Maintenance of product records in Reliant Archiving activities Tender document requests

**Pharmacovigilance**:
AE/ incident intake case process and follow up Archive cases submission to HA NSS related issue
- communication to HA PBRER submission RMP submission DHPC/ FSN (safety communication) Safety information requested by HA PVA- alternate projects
- (non-exhaustive list, delegated as necessary)_

Primary skills include but are not limited to:
Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals. Communication Skills: Demonstrates good communications skills to convey and receive information in English and local language. Problem Solving: Demonstrates good skills in problem solving Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations. Decision Making: Demonstrates strong skills to utilize knowledge, networks and data to make rapid and appropriate decisions with management oversight and to determine when escalation of issues is necessary. Regulatory and Compliance Management: Demonstrates knowledge of PV and RA regulations and regulatory trends.

Must have requirements:

- a minimum of 3 year of industry experience in in pharmacovigilance and/or regulatory affairs.

Pharmacist with licence A holder

**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.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**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**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R524187

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