Regulatory Affairs Associate

iNova Pharmaceuticals; Philippines; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

iNova Pharmaceuticals seeks a Regulatory Affairs professional to support the RA Manager in registering and maintaining product registrations and licenses in the Philippines. You will support regulatory, quality and medical affairs activities and ensure compliance across the business.

The role requires a licensed pharmacist with a Bachelor’s degree in Pharmacy, at least 3 years in pharma or FMCG, and knowledge of local labeling and regulatory processes.

Qualifications

• Licensed Pharmacist with a Bachelor’s degree in Pharmacy.
• Minimum 3 years experience in pharmaceutical or FMCG.
• Knowledge of Philippines regulatory environment and labeling controls.
• Experience with western multinational pharmaceutical companies is desirable.

Responsibilities

• Assist in product registrations and maintenance of licenses in line with company strategy.
• Ensure ongoing compliance with regulatory and business obligations.
• Collaborate with Regulatory Affairs Manager to stay updated on product registrations and market segments.
• Review promotional materials for compliance with Codes of Conduct.
• Assist with advertisement permits when required.
• Support management in maintaining regulatory compliance systems.
• Maintain regulatory databases and provide periodic updates to the RA Manager.
• Build relationships with regulatory agencies and pharmaceutical associations.

Skills

Regulatory affairs

Project management

Documentation control

Regulatory communications

Education

Bachelor’s degree in Pharmacy

Licensed Pharmacist

Job description

The Company

iNova is a different kind of health company.We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East &Africaand Europe. Experience the iNova difference today.

The Opportunity

This role will support/assist the RA Manager in the registration and maintenance of product registrations and company licenses, managing all regulatory, quality and medical affairs related activities and ensure full regulatory compliance in in the Philippines.

Key Accountabilities & Performance Indicators

• Assists in the product registrations in line with company strategy to ensure compliance withlocal regulatory and company requirements.
• Assists in the ongoing compliance and maintenance of product registrations to meetregulatory and business obligations.
• Work closely with Regulatory Affairs Manager to ensure a high level of current knowledge ismaintained regarding product registrations, and maintenance of products within the marketsegments the business aims to conduct its business.
  
• Helps in ensuring promotional materials and communication to HCPs, customers and endusers are reviewed in line with the company and industry Codes of Conduct.
  
• Apply for advertisement permits when required.
  
• Assist and support the management representative in:
• Ensuring that iNova’s regulatory compliance system is established,implemented and maintained.
• Ensuring awareness of obligations to comply with regulatory requirements,any other applicable statutory requirements and any decision thereof madeby top management throughout the establishment and supply chain.
• Ensuring document control procedure is meeting iNova’s requirement
• Work closely with Regulatory Affairs Manager and relevant functional department(s) to ensure outsourced activities are controlled and monitored within the scope of GXP.
  
• Approve product labels or artworks for production.
  
• Approve repack and relabel instructions for products.
  
• Provide technical assistance to relevant departments on regulatory matters such asassistance in the inclusion of products in the formulary and educating customers aboutregulatory guidelines.
  
• Regularly update regulatory databases/monitoring records and provide periodic updates to Regulatory Affairs Manager.
  
• Establish and maintain good relationships with applicable regulatory agencies and pharmaceutical associations to be up to date with local guidelines.
  
• Comply with the PHAP Code of Practice and all applicable Philippine laws and regulations.

About You

To be successful in this role, you will possess the following qualifications and attributes:

• Licensed Pharmacist; Bachelor’s degree in Pharmacy
• Minimum of 3 years experience in pharmaceuticalor in FMCG industry
  
• Knowledge with the regulatory environment in Philippines and have an understanding of labelling regulations and controls.
  
• Knowledge and familiarize in working with western multinational companies in pharmaceuticals/ medical devices/herbal and natural medicines/ dietary supplements
  
• Flexible and capable of prioritizing projects, meeting deadlines and working well under pressure
  
• Strong project management and organizational skills