453 Regulatory Affairs Specialist jobs in the Philippines

Regulatory Specialist:

· Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry

· At least 1 year exposure to Pharmacovigilance and FDA promo permit submission

· Knowledgeable in regulatory requirements for consumer health products

· Must be proficient in MS Word, Excel, and Outlook

· Detail oriented and with strong organizational and time management skills

· Highly flexible and adaptable to change

Job Type: Full-time

Benefits:

• Company events
• Employee discount
• Flextime
• Health insurance
• Life insurance
• Paid training
• Work from home

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
• Can work under pressure with minimum supervision and with self-initiative
• Amenable to work onsite in Alabang, Muntinlupa City

Responsibilities:

• Prepare product specifications and related information upon request
• Coordinate with internal and global regulatory team to ensure that the registration dossier meet the requirements of PH FDA and properly manage and resolve the issues.
• Responsible for product submission in PH FDA e-submission system
• Deal with PH FDA on any matters such as importing and exporting product licenses, manufacturing license and certificate of free sale
• Support artwork and product claims reviews upon request
• Others as assigned for regulatory affairs' activities

Qualifications:

• Bachelor's degree in food science, Food Technology, Biotechnology, Biochemistry, Agricultural industry or related fields
• Good command of spoken and written English
• 3 – 5 years' experience in regulation or Food product registration
• Able to work independent, travel to FDA, Understanding process to contact PH FDA

The Regulatory Affairs Specialist shall provide technical

support to legal and registration activities of the RA

Department in compliance to the regulatory requirements

as mandated by specific regulatory agencies.

JOB OVERVIEW:

The Regulatory Affairs Specialist is responsible for managing all regulatory affairs, documentation, and follow-up transactions with the FDA and LGUs. He/She ensures that all company products comply with legislative requirements, secures and maintains updated permits and licenses, and oversees Grifols logistics.

TASK LIST:

• RA Compliance
• Permits & Licenses
• Product Documentation and Registration
• Grifols Logistic Oversight

QUALIFICATIONS:

• Graduate of BS Pharmacy; must be a Licensed Pharmacist
• At least 1 year as RA Specialist or Officer
• Knowledgeable in FDA QPIRA for Medical Devices, Regulations of LGU such as Mayor's Permit Sanitary, Fire, SEC, DDB, BOC, PhilGEPS and BIR ( Non-taxation transaction)
• Keen on details

OFFICE ADDRESS:

14A 3rd St. New Manila, Quezon City

Job Types: Full-time, Permanent

Benefits:

• Additional leave
• Company Christmas gift
• Company events
• Free parking
• Health insurance
• Life insurance
• On-site parking
• Opportunities for promotion
• Paid training
• Pay raise
• Promotion to permanent employee

Work Location: In person

MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision.

Applies subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Associates Degree (± 13 years)

Experience/Background

Minimum 1 year