Head of Regulatory Affairs

5 days ago


Singapore KellyOCG Sdn Bhd Full time

**DESCRIPTION**:
Responsible for managing the product registration chain, compliance with all regulatory authorities and Global Regulatory Affairs guidance, maintenance of product licenses, and relevant Life Cycle Management (LCM) activities in ROPU ASKAN.

The position functions as the link between global RA functions and provides functional leadership to RA teams in ROPU ASKAN countries.

Responsible for pharmacovigilance (PV) of the Animal Health products and the ROPU PV system in compliance with local regulations and Global PV guidance, including training of all employees on PV responsibilities in ROPU ASKAN.
Contributing to the successful development of the Animal Health business by executing global and regional regulatory affairs (RA) strategies as well as managing local RA and pharmacovigilance (PV) teams and processes.

**DUTIES & RESPONSIBILITIES**
- Translate the Global Animal Health Regulatory Affairs Strategy into a ROPU Animal Health RA Strategy; Align the regional and local regulatory strategies and issues with other businesses/functions and monitor the implementation of ROPU RA strategy; Foster best practice, learning and knowledge sharing and synergies across the ROPU.
- Responsible for the management of product registration activities, in accordance with corporate policies and strategic direction of Global RA and according to the particularities and legislation required by ROPU ASKAN countries. Coordinates all involved functional and cross-functional stakeholders and proactively addresses critical topics, to ensure all milestones are kept and timely registrations/variations are ensured. Monitor regulatory and quality requirements and relevant legislation as well as a consequence assessment for the current Marketing Authorizations.
- Ensure internal support is provided to other departments (Marketing, Supply Chain and QA). Support technical documentation and knowledge for QA, the Local Advisory Committee (Product Recalls), and Supply Chain Management in the case of importation document requirements.
- Responsible for maintaining and updating the global RA databases. Lead and manage the activities of ROPU RA and OPU RA in order to obtain and maintain licenses, renewal and changes in product registrations.
- Monitors and improves a ROPU PV data collection and reporting system. Ensures correctness, completeness and reliability of PV information. Assessment/Global submission of AERs on time. Act as contact for Global PV and local health authorities.
- Ensures local PV training of all ROPU personnel and documentation thereof. Ensures presence of appropriate PV system and training.
- Representing the RA needs and local business related RA priorities in SBU and Global RA/R&D teams. Build, lead and manage the RA teams across ROPU ASKAN.

**REQUIREMENTS**:

- Masters degree (e.g. MSc) in Veterinary Medicine, Pharmacy or Human Medicine.
- Knowledge of Regulatory and pharmacovigilance policy, regulations and procedures. Good knowledge of pharmaceutical terminology and understanding of the development process of a Veterinary Medicinal Product through the system from the final development of the product, through the regulatory procedures at the authorities and final approval and launch of product.
- Solid experience in the pharmaceutical/life science/animal health industry
- Strong written & verbal communication skills along with excellent interpersonal skills and demonstrated ability to develop stakeholder relationships.
- Ability to lead and coordinate diverse groups of professionals.
- Demonstrated ability to lead, collaborate and deliver results in a highly matrix organization.

**Job Types**: Full-time, Permanent

Schedule:

- Day shift



  • Singapore Keller Executive Search Full time

    The Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, overseeing regulatory submissions, and liaising with regulatory bodies. Job...


  • Singapore FACEBOOK SINGAPORE PTE. LTD. Full time

    Meta Singapore is seeking a Head of Regulatory Affairs to lead our regulatory efforts in the APAC region. The ideal candidate will have experience in advising on and representing companies in significant regulatory inquiries and a strong background in handling regulatory and litigation matters.The successful candidate will be responsible for advising on...

  • Regulatory Affairs

    2 weeks ago


    Singapore RESPIREE PTE. LTD. Full time

    Roles & ResponsibilitiesRoles & ResponsibilitiesThe RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and...


  • Singapore Talentreq Partners Pte Ltd Full time

    APAC regulatory affairs - Pharmaceutical industry - Singapore registered pharmacist Reporting to the Head of Regulatory Affairs, you will be responsible for assimilating knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. You will provide strategic...


  • Singapore CAMBRIDGE ADVISERS PTE. LTD. Part time

    Corporate Secretarial & Compliance ConsultingCambridge Advisers Pte. Ltd. is seeking a Head of Secretarial Services and Regulatory Affairs to join our team. In this role, you will be responsible for providing expert advice on corporate secretarial and compliance matters to our clients. Your primary duties will include advising clients on company...


  • Singapore MSD Full time

    ** Join the premier biopharmaceutical company** that has been in Asia Pacific for over 60 years. - Bring your **entrepreneurial** **curiosity** and **learning spirit **into a career of **purpose**, **personal growth**, and **leadership.** - Your chance to be in a regional leadership role and at the centre of strategic excellence. Our Regulatory Affairs team...


  • Singapore TALENTREQ PARTNERS (PTE. LTD.) Full time

    APAC coverage - Pharmaceutical industry - Dynamic work environment Reporting to the Head of Regulatory Affairs, you will be responsible for assimilating knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. You will provide strategic regulatory inputs to the...


  • Singapore Mastercard Full time

    Our Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...


  • Singapore Artixio Consulting Pvt Ltd Full time

    This is a full-time hybrid role as a Regulatory Affairs Manager at Artixio. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining quality systems. The role is based in Singapore but allows for some remote work. **Qualifications** - Minimum...


  • Singapore Hays Full time

    **Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...


  • Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    **About APACMed** Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully committed to facilitating...


  • Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...


  • Singapore RESPIREE PTE. LTD. Full time

    At RESPIREE PTE. LTD., we are seeking a highly skilled Regulatory Affairs Manager to oversee regulatory compliance and quality assurance functions within our organization. This is an exciting opportunity for a seasoned professional with expertise in the medical device industry.Key ResponsibilitiesPrepare high-quality technical documentation.Manage regulatory...


  • Singapore ABIORES PTE. LTD. Full time

    Develop and implement regulatory strategies to secure product approvals more quickly than competitors. - Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment. - Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines. -...


  • Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...


  • Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

    **PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...

  • Regulatory Affairs

    4 days ago


    Singapore MANDARIN OPTO-MEDIC CO PTE LTD Full time

    **Duties**: - Manage renewal processes of medical device for maintaining regulatory compliance - Facilitate the dissemination of documentation (eg. Letter of Authorization, Free Sales Certificates, Certificates of Origin, etc) to both internal and external parties - Serve as internal consultant for basic regulatory affairs support involving issues such as...


  • Singapore BeZero Carbon Full time

    **About us**: BeZero Carbon’s mission is to scale investment in environmental markets that deliver a sustainable future. We are a carbon ratings agency. We equip world-leading organisations with the knowledge, tools and confidence to make better climate decisions. BeZero Carbon is the largest global ratings agency for the Voluntary Carbon Market. We are...


  • Singapore Santen Full time

    Company Description Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people...


  • Singapore DSM-Firmenich Full time

    COMPANY DESCRIPTION As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create...