Regulatory Officer

SYDENHAM Laboratories, Inc.; Cavite City; On-site; PHP 312,000 - 402,000; Full time

Benefits offered by this job

Health & wellness insurance

Health Insurance

Life Insurance

Professional development

Scholarship program

Job summary

SYDENHAM Laboratories, Inc. in Cavite is seeking a Regulatory Affairs professional. The role involves reviewing and submitting regulatory submissions for pharmaceutical products, and collaborating with cross-functional teams to ensure compliance across the product lifecycle.

Ideal candidates will have a Pharmacy degree with license, plus knowledge of local and international regulatory requirements. Strong communication and attention to detail are essential in a fast-paced environment.

Qualifications

• Bachelor of Pharmacy and Philippine license required.
• Regulatory affairs experience in pharma is an advantage.
• Strong knowledge of local and international regulatory requirements.
• Excellent communication and presentation skills; ability to translate regulatory info clearly.
• Attention to detail in a fast-paced, deadline-driven environment.

Responsibilities

• Review regulatory submissions for new and existing pharmaceutical products.
• Prepare and submit regulatory filings to local authorities.
• Collaborate with cross-functional teams to ensure regulatory compliance across the product lifecycle.
• Stay up-to-date with changes in regulatory requirements and guidelines.
• Assist in development and implementation of regulatory strategies.
• Maintain comprehensive documentation and records related to regulatory activities.

Skills

Regulatory affairs experience

Regulatory knowledge

Communication skills

Education

Bachelor of Pharmacy

Philippine Pharmacy License

Tools

Regulatory submission software

Job description

On-site - Cavite No Exp Required Bachelor Full-time

Job Description

Government Mandated Benefits

• Insurance Health & Wellness
• Health Insurance, Life Insurance
• Professional Development
• Professional Development, Scholarship Program

What you'll be doing

• Reviewing and evaluating regulatory submissions for new and existing pharmaceutical products
• Preparing and submitting regulatory filings to local authorities
• Collaborating with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
• Staying up-to-date with changes in regulatory requirements and guidelines
• Assisting in the development and implementation of regulatory strategies
• Maintaining comprehensive documentation and records related to regulatory activities

What we're looking for

• Degree in Pharmacy and a valid Philippine pharmacy license is required for this position.
• Experience in a Regulatory Affairs role within the pharmaceutical industry is an advantage
• Thorough understanding of local and international regulatory requirements of the pharmaceutical industry
• Excellent communication and presentation skills, with the ability to translate complex regulatory information into clear and concise language
• Strong problem-solving and critical thinking skills
• Attention to detail and the ability to work in a fast-paced, deadline-driven environment
• Familiarity with regulatory submission software and document management systems