696 Regulatory Pharmacist Officer jobs in the Philippines

The 
Regulatory Affairs Senior Specialist – Partnered Product
 manages the regulatory, quality and compliance aspects of partnering activities, ensuring smooth transitions and compliance for in-licensed and out-licensed products.

Qualifications:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities, preferably with experience with in-licensing and out-licensing
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

1. 
Due Diligence and Assessment

• Evaluate regulatory dossiers of in-licensed products for compliance and market readiness
• Conduct risk assessments for out-licensed products in collaboration with partners

2. 
Regulatory Submissions

• Support the registration of in-licensed products by reviewing and compiling required documentation.
• Prepare regulatory packages for out-licensed products to met partner and local requirements

3. 
Partnership Coordination

• Act as the primary regulatory contact for in-licensing and out-licensing partners
• Ensure timely updates and compliance with contractual obligations related to regulatory matters

4. 
Regulatory Intelligence

• Monitor regulatory landscapes in key markets to support licensing decisions
• Provide input on regulatory feasibility and timelines during partnership negotiations

5. 
Renewals and Life-cycle Management

• Manage lifecycle activities like renewals, variations, and periodic reporting for licensed products
• Ensure alignment with the partner's and authority's requirements for partnered products

6. 
Documentation and Communication

• Maintain detailed records of in-licensing and out-licensing regulatory agreements
• Prepare clear, concise reports for internal and partner updates

7. 
Quality Assurance and Compliance

• Collaborate with partners to ensure compliance with Good Manufacturing Practices (GMP) and quality standards o Review and assess quality agreements with in-licensing and out-licensing partners
• Support deviation management, change controls, and corrective actions related to partnered products
• Ensure quality compliance during product transfers, batch releases, and post-market surveillance
• Review marketing materials to ensure compliance with regulatory and global guidelines
• Ensure that promotional content aligns with local and partner market regulations
• Collaborate with internal teams and partners to address regulatory and global concerns in advertising and promotional strategies
• Monitor post-market promotional activities for compliance with regulatory standards

The Regulatory Affairs Senior Specialist supports the preparation and submission of regulatory documents, ensuring compliance with local and international pharmaceutical regulations. The role involves liaising with regulatory authorities to ensure timely approvals and maintaining regulatory compliance for pharmaceutical products.

Technical Skills:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities.
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

1. Regulatory Submissions:

Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.

Liaise with regulatory authorities to follow up on submissions and address queries or deficiencies promptly.

2. Documentation Management:

Organize and maintain regulatory files, records, and databases to ensure accurate tracking of submissions and approvals.

Ensure all regulatory documentation is complete, accurate, and compliant with relevant guidelines.

3. Compliance Monitoring:

Monitor updates in regulatory requirements and guidelines and assist in implementing necessary changes.

Review labeling, packaging, and promotional materials to ensure regulatory compliance.

4. Cross-Functional Support:

Collaborate with internal teams (e.g., Quality, Manufacturing, Marketing) to gather required documents and data for regulatory purposes.

Provide regulatory support during product development and lifecycle management.

5. Communication with Authorities:

Serve as a primary contact for regulatory authorities, ensuring effective communication and addressing regulatory concerns.

Maintain strong working relationships with key stakeholders in regulatory agencies

Job Types: Full-time, Permanent, Fixed term

Pay: Php40, Php60,000.00 per month

Benefits:

• Paid training
• Pay raise

Education:

• Bachelor's (Preferred)

License/Certification:

• Licensed Pharmacist (Required)

Work Location: In person

• Graduate of Bachelor of Science in Pharmacy.
• Licensed and Registered Pharmacist (RPh) with a valid, unexpired PRC identification card.
• Preferably with at least one (1) year of relevant work experience in the field.
• Possesses excellent organizational and planning skills.
• Demonstrates a strong sense of responsibility, able to work independently with minimal supervision, resourceful, and capable of performing well under pressure.
• Proficient in computer applications, with above-average technical skills.
• Strong communication abilities; highly organized, detail-oriented, accurate, and able to multi-task effectively.
• Must be willing to be assigned in Greenhills, San Juan City.
• Dynamic fresh graduates are also encouraged to apply.

Job Type: Full-time

Pay: Php20, Php25,000.00 per month

Application Question(s):

• Are you amenable to work onsite in San Juan (NCR)?

Work Location: In person

Responsibilities:

Deals with and takes care of regulatory issues and carries out the plan to make sure the company complies with regulations

Establishes procedures and systems to make sure that all required filings, certifications, and

permits are completed and kept track.

Collate, Prepare registration requirements and Liaise with respective regulatory agencies in

securing appropriate License and Product Registration.

Keeping up to date with changes in regulatory legislation and guidelines.

Documenting the product classifications that need regulations and protocols.

Ensures that company's products comply with the regulations of the regions where they should be distributed (BFAD, PEDEA, FDA, CNDM, PMPIN, etc.)

Prepares and submits applications and reports to applicable regulatory agencies.

Ensures that quality standards are met and submissions meet strict deadlines

Remain current with regional, national, and worldwide laws, regulations, and consumer behavior

Examines business practices and procedures and offers suggestions for system improvements

Coordinates and liaises for timely, effective, ethical, and strategic adherence to local regulatory requirements

Assures orderly filing, thoroughness, confidentiality, adherence to the companies' standards, and readiness for local audits.

To review, analyze, prepare and assemble regulatory documents needed per shipment.

Ensures product information, permits and licenses are updated and accessible.

Assisting the IMPEX on the shipments related concerns

Maintain the updated files of product registration and regulatory compliance documents.

Coordination with the the ImpEx Officer.

Secure licenses and certificate of the company. (e.g., BOC Permit, BFAD, FDA, etc.,)

Ensure that quality standards are met and submissions meet strict deadlines.

Performs other related duties as required and assigned.

Support Individual department heads on creation/update on their SOP and Policies.

Qualifications:

Graduate of BS in Pharmacy or other related courses.

Relevant work experience is preferred but not required

Excellent written and verbal communication skills

Good coordination skills and keen attention to details

Must be a team-player and understands the role as part of a bigger group and knows how the job integrates with that of other teams and departments in achieving a common goal.

Proficient in MS applications

Attentive to detail and maintain an organized work environment.

Strong decision-making and leadership capability, and a team-player

Training & Certifications

Honest and trustworthy.

Can work under pressure with minimum supervision and with self-initiative

Amenable to work onsite in Alabang, Muntinlupa City

Job Type: Full-time

Work Location: In person

About the role

Reporting to the Head of Regulatory Affairs, this full-time Regulatory Affairs Officer position at Square Pharmaceutical, Inc' is a crucial role within the company's Science & Technology team. Based in Carmona Cavite, this role will be responsible for ensuring Square Pharmaceutical's products meet all relevant regulatory requirements and guidelines.

What you'll be doing

• Prepare and submit regulatory applications and documentation to governing bodies such as the FDA and EMA
• Monitor changes in regulations and guidelines, and advise the business on the impact and required actions
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
• Lead regulatory inspections and audits, and manage any resulting corrective actions
• Build and maintain strong relationships with key regulatory authorities
• Contribute to the development and implementation of the company's regulatory strategy

What we're looking for

• In-depth knowledge of global regulatory requirements and guidelines for pharmaceutical products
• Excellent written and verbal communication skills, with the ability to translate complex regulatory information
• Strong project management and problem-solving skills, with the ability to work independently
• Graduate of BS Pharmacy (licensed or not welcome to apply)

What we offer

• Dynamic, collaborative work environment with supportive colleagues

About us

Square Pharmaceutical, Inc' is a pharmaceutical company dedicated to developing and manufacturing high-quality medications. With a strong focus on innovation and quality, we are committed to advancing the standards of healthcare through our diverse portfolio of products and solutions.

If this role sounds like the perfect next step in your career, we encourage you to apply now.

Company Description

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Role Description

This is a full-time on-site role for a Regulatory Affairs Officer located in Manila. The Regulatory Affairs Officer will be responsible for preparing and coordinating regulatory documentation, ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining up-to-date knowledge of regulatory affairs. The officer will also oversee internal audits and liaise with various departments to ensure that all operations are compliant with relevant regulations.

Qualifications

• Strong understanding of Regulatory Documentation and Regulatory Requirements
• Experience in Regulatory Compliance and Regulatory Submissions
• Proficiency in managing Regulatory Affairs
• Excellent written and verbal communication skills
• Keen attention to detail and strong organizational skills
• Ability to work independently and collaboratively within a team
• Bachelor's degree in Life Sciences, Pharmacy, or related field
• Previous experience in the pharmaceutical industry is a plus