Regulatory Affairs Department Head

23 hours ago

Santa Maria, Calabarzon, Philippines HRTX Full time


Location: Laguna

Work Schedule: Monday to Friday, 8:00 AM to 5:00 PM

Set Up: Onsite role About the Role
The Regulatory Affairs Department Head will oversee all regulatory submissions, renewals, and compliance initiatives for both local and export markets. You will manage a small team, guide regulatory strategy, and collaborate closely with cross-functional departments to ensure timely and accurate documentation.
This role plays a critical part in ensuring the organization meets all regulatory standards while supporting client requirements and maintaining up-to-date knowledge of industry regulations.
Key Responsibilities
  • Lead the regulatory team in managing product registrations, renewals, and compliance activities.
  • Review and approve technical dossiers for local and international submissions.
  • Coordinate with Technical Services, QA, QC, Formulation, Marketing, and other internal groups to ensure complete documentation.
  • Liaise with regulatory agencies and client regulatory counterparts.
  • Monitor regulatory changes and provide updates to internal stakeholders.
  • Serve as the Pharmacovigilance Officer and ensure adherence to reporting requirements.
  • Maintain updated databases of regulatory documentation and regional requirements.
Leadership Responsibilities
  • Direct management of a Regulatory Affairs Manager, Regulatory Affairs Associate, and Company Pharmacist.
  • Oversight of an indirectly supervised Technical Clerk.
  • Work under general supervision of the R&D/Regulatory Division leadership.
Qualifications
  • Licensed Pharmacist with a degree in Pharmacy or Industrial Pharmacy.
  • Minimum of 5 years of experience in regulatory affairs or product registration within manufacturing (pharmaceutical, food, or cosmetics preferred).
  • Strong understanding of FDA regulations and other government regulatory frameworks.
  • Knowledge of GMP, ISO 9001:2015 basics, EHS, QMS, and licensing processes.
  • Excellent attention to detail, documentation skills, and communication abilities.
  • Proficiency in basic computer applications.
Additional Skills
  • Strong problem-solving and decision-making capability
  • Root cause analysis
  • Project management
  • Customer service orientation
  • Performance management
Working Environment
  • Clean, well-organized office setup
  • Hybrid of desk work and occasional field activities
  • Collaboration with internal teams and external regulatory bodies

  • Regulatory Affairs Department Head

    24 hours ago

    Santa Maria, Calabarzon, Philippines HRTX Full time

    **Location: LagunaWork Schedule: Monday to Friday, 8:00 AM to 5:00 PMSet Up: Onsite role About the RoleThe Regulatory Affairs Department Head will oversee all regulatory submissions, renewals, and compliance initiatives for both local and export markets. You will manage a small team, guide regulatory strategy, and collaborate closely with cross-functional...

  • Regulatory Affairs Manager for Food Manufacturing

    1 week ago

    Pulong Santa Cruz, Calabarzon, Philippines Foodflow Inc. Full time ₱900,000 - ₱1,200,000 per year

    QUALITY ASSURANCE AND REGULATORY AFFAIRS MANAGERWe are looking for a person with a technical background in food manufacturing, to be the internal lead and manage the team dealing with all quality assurance, and issues relating to achieving regulatory compliance.JOB DESCRIPTION:Author and refine procedures, instructions, templates, and our quality manual to...

  • Regulatory Specialist Assistant

    22 hours ago

    Pulong Santa Cruz, Calabarzon, Philippines Sterling Pacific Ventures Corp. Full time

    A Regulatory Specialist Assistant ensures that an organization's products, services, and operations comply with industry regulations and government requirements. They prepare and submit documentation for regulatory approval, monitor compliance with laws and standards, and advise teams on regulatory strategies. Their work helps companies avoid penalties,...

  • Regulatory Science

    24 hours ago

    Pulong Santa Cruz, Calabarzon, Philippines Ivoclar Vivadent Services & Support, Inc. Full time

    Shape the Future of Dentistry with UsAt Ivoclar, we are dedicated to making people smile – and we want you to be part of it As a Regulatory Affairs Manager - Documentation, you will play a pivotal role in ensuring regulatory compliance for our innovative products. This is an exciting opportunity to collaborate with international teams in product...

  • Head merchandiser

    22 hours ago

    Pulong Santa Cruz, Calabarzon, Philippines Private Advertiser Full time

    Job Description – Head Merchandiser (Bra Manufacturing)Position OverviewThe Head Merchandiser in a bra manufacturing company oversees the entire merchandising process—from product development to delivery—ensuring that designs meet market trends, quality standards, and customer requirements. This role bridges the gap between design, production, and...

  • HRGA Supervisor

    1 week ago

    Pulong Santa Cruz, Calabarzon, Philippines FURUKAWA ELECTRIC THERMAL MANAGEMENT SOLUTIONS AND PRODUCTS LAGUNA, INC. Full time ₱1,200,000 - ₱2,400,000 per year

    Job Description:This position is responsible for overseeing the entire end to end training and development process, in which the training needs analysis is conducted with department heads to ensure programs implemented meet the goals of the company and are evaluated so that effectiveness can be considered periodically. The supervisor also formulates and...

  • HR Staff

    24 hours ago

    Pulong Santa Cruz, Calabarzon, Philippines FURUKAWA ELECTRIC THERMAL MANAGEMENT SOLUTIONS AND PRODUCTS LAGUNA, INC. Full time

    The HR Staff is responsible for supporting the organization's talent acquisition, onboarding and offboarding management, implementing training and development programs, employee engagement initiatives, and performance management processes to support workforce growth and organizational effectiveness. This role plays a crucial part in ensuring adequate...

  • Quality Assurance Division Manager

    7 days ago

    Pulong Santa Cruz, Calabarzon, Philippines HRTX Full time ₱1,500,000 - ₱2,500,000 per year

    Position: Quality Assurance Division ManagerDepartment: Quality AssuranceReports to: President and Chief Executive OfficerThe Quality Assurance Division Manager is responsible for overseeing the companys Quality Assurance and Quality Control functions. The role ensures that raw materials, packaging materials, in-process batches, and finished products meet...

  • Scientific Communications Specialist

    22 hours ago

    Pulong Santa Cruz, Calabarzon, Philippines Ivoclar Full time

    Shape the Future of Dentistry with UsWe are seeking aScientific Writerto join our Team. In this role, you will be responsible for documenting study results for internal and external communication materials, supporting critical analysis and evaluation of studies, and ensuring high-quality scientific content.Key ResponsibilitiesPrepare and edit scientific and...

  • Finance Assistant

    7 days ago

    Pulong Santa Cruz, Calabarzon, Philippines Unilab Full time ₱150,000 - ₱250,000 per year

    (for a Unilab Group Manufacturing Subsidiary)It is the spirit of Bayanihan that drives us to continue our legacy of excellence and commitment to care. As an organization, we achieve our successes through good, honest, and persevering hard work - TOGETHER. It is in this way in which our company was built; we progressed as the country's leading Pharmaceutical...