Regulatory Affairs Manager (Pharmacist)

Biocostech Philippines Corporation; Mandaluyong; On-site; PHP 670,000 - 1,004,000; Full time

Benefits offered by this job

Career Growth

Learning opportunities

Company perks for qualified candidates

Free monthly skin care products forAll

Birthday cakes for monthly birthday

Job summary

Biocostech Philippines Corporation is seeking a licensed Pharmacist to serve as the Official Regulatory Pharmacist. The role involves liaising with the FDA on licenses and registrations, reviewing documentation for product registration, and ensuring licenses and permits are current.

The candidate should have 2–3 years in regulatory affairs, with exposure to food/cosmetic sectors as an advantage. The position also includes cross-department collaboration, QA involvement, and maintaining compliance

Qualifications

• Candidate must possess at least Bachelor’s degree in Pharmacy.
• Must be a Licensed Pharmacist.
• At least 2-3 years working experience with the regulatory affairs or experience in the related field is required for the position.
• Regulatory experienced in the food and cosmetic industry is an advantage.
• Background in QA, Production & Research & Development is also an advantage.
• Knowledgeable with the local legal and regulatory procedures, policies, and guidelines.
• Ability to collaborate effectively across departments to identify and implement compliance improvements.
• Strong analytical, organizational skills and possess a good leadership style.
• Possess excellent interpersonal skills and communication skills.
• Strong in attention to detail and accuracy.

Responsibilities

• Represent the company as the Official Pharmacist for legal and regulatory affairs.
• Liaise with the FDA on regulatory activities, licenses and permits, IPO for trademark and Halal applications.
• Evaluate and assess documents for FDA submission (product registration, licenses, permits, promotions, variations).
• Ensure all licenses, certificates, and permits are updated and valid.
• File, monitor, and follow up on FDA applications.
• Implement corrective actions for regulatory non-compliances and risk mitigation.
• Check/approve product labels/packaging for registration and FDA compliance.
• Keep updated on relevant laws and regulatory circulars.

Skills

Licensed Pharmacist

Regulatory affairs

Analytical skills

Leadership

Communication skills

Cross-department collaboration

Attention to detail

Strong organizational skills

Education

Bachelor’s degree in Pharmacy

Job description

Job Responsibilities:

• Represent the company as the Official Pharmacist for legal and regulatory affairs.

• Liaise with the Food & Drug Administration (FDA) on matters about regulatory activities, licenses and permits, IPO - for trademark applications, and Halal applications.

• Evaluate and assess the completeness and quality of technical documents for submission to the FDA (Product registration -initial & renewal, license to operate, promotions, trademarks, variations, and compliances).

• Ensures that all licenses, certificates, and permits are updated and valid.

• File, monitor, and closely follow up on the status of applications with the FDA.

• Correcting product registration non-compliances and fulfilling deficiencies; implementing compliance plans and strategies.

• Checks/approves product labels/packaging materials for the registration of new products as per Marketing requirements and that conforms to FDA standards.

• Makes regular updates on laws and regulations but is not limited to new Administrative Orders FDA Circulars and other memoranda issued by health authorities.

• Continuous coordination with the manufacturers on regulatory requirements and complying with all input in the safekeeping of the PIF.

• Acts as custodian of confidential regulatory documents for proper reference and easy access.

• Attends to the needs of trade accounts especially when clarifying issues with products.

• Supervise the QA Specialist and ensure productivity and efficiency.

• Cascading standard regulatory requirements and processes to concerned units.

• Specifying storage, labeling and packaging requirements.

• In charge of Quality Control checking, sample and test mapping of products subjected for stability. Safe keeping of all Quality Control and Retention samples.

• Schedules monthly pest control services.

• Prepares needed permit during shipments.

• Schedules yearly calibration of Thermo-hygrometers and weighing scales.

• Submits monthly damages items for employee sale and expired items for disposal when needed.

• Actively identifies gap and ensure to propose or implement changes and resolutions necessary to cover risks.

• Responsible in carrying out Company policies and procedures within the organization.

• Perform services for Bicosotech Philppines Corporation its affiliates and its subsidiaries.

Qualifications:

• Candidate must possess at least Bachelor’s degree in Pharmacy.

• Must be a Licensed Pharmacist.

• At least 2-3 years working experience with the regulatory affairs or experience in the related field is required for the position.

• Regulatory experienced in the food and cosmetic industry is an advantage.

• Background in QA, Production & Research & Development is also an advantage.

• Knowledgeable with the local legal and regulatory procedures, policies, and guidelines.

• Ability to collaborate effectively across departments to identify and implement compliance improvements.

• Strong analytical, organizational skills and possess a good leadership style.

• Possess excellent interpersonal skills and communication skills.

• Strong in attention to detail and accuracy.

Job Highlights:

• Career Growth

• Learning different aspects of the business

• Company perks for qualified candidates!

• Free monthly skin care products for all

• Birthday cakes for monthly birthday celebrants!