Regulatory Affairs Associate

2 days ago

Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time ₱600,000 - ₱1,200,000 per year

Duties and Responsibilities

Regulatory Submissions & Filings

  • Support in preparing and submitting regulatory documents, including applications for product registrations, licenses, and other approvals required by the FDA Philippines and related agencies.
  • Draft and review dossiers for product registration, renewals, variations, and other filings.
  • Monitor submission timelines, track progress, and ensure timely completion of all regulatory requirements.

Regulatory Compliance & Advisory

  • Provide guidance to internal teams (R&D, manufacturing, quality control) to ensure compliance with local regulatory standards.
  • Review product labeling, advertising, and promotional materials to confirm alignment with Philippine regulations.
  • Stay informed on changes in laws and regulatory guidelines; update internal stakeholders on new or revised requirements.

Communication with Authorities

  • Act as the company's liaison with FDA Philippines, DOH, and other government agencies.
  • Assist in preparing responses to agency queries and follow up on pending submissions.
  • Support the team during audits, inspections, and regulatory evaluations.

Post-Market Surveillance

  • Assist in monitoring product compliance after launch through post-market surveillance activities.
  • Help prepare required reports such as Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and others.
  • Support product recall activities when necessary, ensuring compliance with regulatory procedures.

Documentation & Records Management

  • Maintain well-organized records of regulatory submissions, approvals, and communications.
  • Ensure documents are updated and readily available for audits or inspections.
  • Keep detailed logs of company interactions with FDA Philippines and other authorities.

Regulatory Research & Market Insights

  • Track local regulatory updates, trends, and industry developments to support compliance.
  • Research and analyze requirements for new products, market expansions, or product changes.

Cross-Functional Collaboration

  • Work closely with legal, marketing, R&D, and manufacturing teams to align product development and marketing with regulations.
  • Contribute to the development of regulatory strategies for new products, ensuring compliance from early stages.

Qualifications

  • Bachelor's Degree in Pharmacy (required).
  • 1–2 years of experience in Regulatory Affairs or Quality Assurance.
  • Strong knowledge of FDA Philippines regulations and cosmetic product registration.

Job Type: Full-time

Benefits:

  • Company Christmas gift
  • Company events
  • Employee discount
  • Opportunities for promotion
  • Paid training
  • Promotion to permanent employee

Education:

  • Bachelor's (Preferred)

Experience:

  • Regulatory Affairs Associate: 1 year (Preferred)

License/Certification:

  • Licensed Pharmacist (Preferred)

Work Location: In person

  • Regulatory Affairs Associate

    4 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time ₱600,000 - ₱1,200,000 per year

    Job Objective:The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA)...

  • Regulatory Affairs Associate

    4 days ago

    Pasay City Central Post Office, Philippines AMBICA INTERNATIONAL CORPORATION Full time ₱200,000 - ₱240,000 per year

    A Regulatory Affairs Associate will work collaboratively with all members of Regulatory Department. He/ She acts a responsible person in filing regulatory documents submitted and received from FDA. He/ She will also be the one who will update Regulatory Reports in which he/she will regularly send to all members of Regulatory Department for their...

  • Regulatory Affairs Associate

    12 hours ago

    Cavite City, Philippines Buscojobs Full time

    Regulatory Affairs Associate jobs in Cavite Legal Assistant Posted today Job Description Work Setup: In-office | Molino, Bacoor, Cavite About Us: Nexventra Corporation is a Philippine-based start-up business process outsourcing (BPO) company. We work closely with our sister company, Nexventra LLC in the U.S., to support law firms by building reliable and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Caloocan, Philippines Exxel Prime Int'l Trading Inc. Full time

    Overview Job Title: Regulatory Affairs Specialist Department: Technical Services Reports To: Technical Services Manager Location: #20 Corner Rose St., Reparo Rd., Barangay 161, Baesa, Caloocan City Work Setup: On-site Employment Type: Probationary (5 months) The Regulatory Affairs Specialist is responsible for ensuring that all products of...

  • Regulatory Pharmacist

    4 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time ₱900,000 - ₱1,200,000 per year

    The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and...

  • QA & Regulatory Affairs Supervisor

    4 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

    QUALITY ASSURANCE:Responsible for the final release of products in the absence of Sr. RA/QA Manager.Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in...

  • Regulatory Affairs Associate

    2 days ago

    Makati City, National Capital Region, Philippines Transmedic Group Full time ₱900,000 - ₱1,200,000 per year

    Job description:Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and...

  • Regulatory Affairs Associate

    2 days ago

    Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱1,200,000 - ₱2,400,000 per year

    Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and...

  • Regulatory Affairs Associate

    4 days ago

    Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱120,000 - ₱180,000 per year

    Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Caloocan, Philippines Lifestrong Marketing Inc. Full time

    Overview Regulatory Affairs Pharmacist ensures our company's FDA compliance with all relevant regulations across our Cosmetics products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules and policies, strong written and oral communication,...