Regulatory Affairs Manager

Organon

2+ years

Not Disclosed

Bangkok

10 Oct. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Regulatory Affairs and Pharmacovigilance Specialist

Position Overview:

The RAaPV Senior Specialist is responsible for managing all aspects of regulatory submissions in assigned markets. This role combines expertise in scientific and regulatory matters to ensure that new and established products comply with local legislation and company procedures. The Senior Specialist will leverage knowledge of regional regulations, authority expectations, and industry trends to collaborate with cross-functional teams, enhance regulatory initiatives, drive compliance, and support supply continuity.

Key Responsibilities:

Develop and communicate product registration plans and strategies in collaboration with cross-functional teams.
Ensure timely submission of post-market regulatory dossiers for authorized products, including variations, GMP clearances, renewal applications, site transfers, and other regulatory requirements.
Maintain and archive regulatory documents in compliance with departmental and local policies.
Ensure compliance with global and local SOPs and assist in preparing corrective and preventative actions (CAPAs) for any non-compliance issues.
Identify procedural gaps and implement solutions in collaboration with stakeholders.
Support drug shortage management and regulatory reporting, collaborating with Quality and Supply Chain teams.
Assist the deputy/back-up Qualified Person for Pharmacovigilance (QPPV) as required and support local PV activities.
Coordinate regulatory activities across the region for assigned projects.
Represent the company in regulatory associations and contribute to regulatory projects as needed.

Competencies:

Inspires Growth: Identifies business needs and champions development.
Delivers with Accountability: Aligns priorities and delivers results on time.
Innovates with Agility: Encourages diverse thinking and creative problem-solving.
Makes Connections: Collaborates effectively with internal and external partners.
Communicates with Optimism and Authenticity: Articulates a shared vision and communicates empathetically.
Activates Belonging: Promotes diverse representation in talent selection and development.

Required Qualifications:

Bachelor’s degree in pharmacy, pharmaceutical sciences, health, life sciences, or a related field.
Minimum of 5 years of experience in regulatory affairs and/or CMC.
Expert knowledge of regulations in the assigned market; knowledge of ASEAN regulations is a plus.
Strong communication and time management skills, with the ability to work independently and collaboratively.
Proficient in negotiation and influencing across various stakeholders.

Who We Are:

Organon delivers innovative health solutions that empower individuals to live their best lives. As a $6.5 billion global healthcare company, we focus on making a difference for women, their families, and communities. Our vision is clear: a healthier and better every day for every woman.

Equal Opportunity Commitment:

As an equal opportunity employer, we welcome diverse applications and are committed to creating an inclusive environment for all candidates.

Search Firm Representatives:

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 will be deemed the sole property of our company. No fee will be paid if a candidate is hired as a result of an agency referral without a pre-existing agreement.

Annualized Salary Range:

To be provided based on local market.

Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: Not available
Travel Requirements: Must satisfy all applicable travel and credentialing requirements.

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Regulatory Affairs Manager

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