Senior Operational Regulatory Affairs Consultant

PharmEng Nordic ApS; Manila; Hybrid; PHP 800,000 - 1,400,000; Full time

Job summary

PharmEng Nordic ApS in Manila, Philippines seeks a Senior Operational Regulatory Affairs Consultant to oversee regulatory projects for the market, develop strategies, and provide regulatory support and intelligence for product registrations. The role includes pharmacovigilance, QA, and project management within a consulting service framework.

Ideal candidates hold a Bachelor’s degree in Pharmacy with 2–3 years in regulatory affairs, PV, and quality system maintenance.

Qualifications

• Bachelor’s Degree in Pharmacy required.
• 2–3 years of experience in regulatory affairs and product registration.
• Experience with pharmacovigilance and quality system maintenance preferred.
• Ability to manage projects to completion within timelines.

Responsibilities

• Regulatory Affairs: oversee regulatory projects and develop strategies for product registration.
• Pharmacovigilance: act as local qualified person for pharmacovigilance reporting and support regional activities.
• Quality Assurance: assist in maintaining Quality Management System and good distribution/storage practices.
• Project Management: contribute to business development and project execution across regulatory, PV, and QA.

Skills

Regulatory affairs

Pharmacovigilance

Quality Assurance

Project Management

Entrepreneurial mindset

Education

Bachelor's Degree in Pharmacy

Job description

Senior Operational Regulatory Affairs Consultant

Manila, PH

Responsibilities:

• Regulatory Affairs: Oversee all aspects of regulatory projects for the market, develop strategies, and offer solutions to clients in product registration. This includes providing regulatory support and intelligence, ensuring compliance review, translation, submission of dossier to local or regional health authorities, and following up on post-approval commitments, life cycle management, etc.
• Pharmacovigilance: Serve as the local qualified person for Pharmacovigilance reporting and provide support to other Pharmacovigilance activities in the region as required.
• Quality Assurance: Assist in maintaining the Quality Management System, particularly in Good Distribution/Storage and Supply Practices for Marketing Authorization Holding.
• Project Management: Participate in business development and project execution related to regulatory affairs, Pharmacovigilance, and quality assurance. This involves a deep understanding of regulations and industry practices, and being adaptable to various scopes within the pharmaceutical consulting service industry.

Supporting Functions:

Be open to new challenges and responsibilities, including general management and marketing of the business. Tasks may include administrative matters such as marketing, branding, business development, managing client and vendor databases, organizing and communicating on training events, etc. Demonstrate interest and initiative in process improvement and company growth. This list is not exhaustive and may vary based on consulting opportunities, offering ample room for career growth and challenges.

Qualifications:

• Bachelor’s Degree in Pharmacy or related field.
• Minimum 2-3 years of experience in regulatory affairs, product registration, submissions to regulatory authorities, pharmacovigilance, and Quality System maintenance. Preference for experience in distribution companies importing foreign pharmaceutical products.
• Entrepreneurial mindset, problem-solving skills, self-driven, mature, and able to work independently or in dynamic environments.
• Ability to manage projects to completion within allocated timelines.
• Resourcefulness in seeking answers to challenging questions regarding the Philippines Regulatory environment.
• Fluency in business English and proficiency in the Philippineslanguage required, both spoken and written, with international experience.
• Experience in commercial regulatory affairs across various classifications, including pharmaceuticals, biologics, cosmetics, health food, medical devices, hazardous chemicals, etc.

We offer full-time, project-based, or part-time flexible working conditions, allowing candidates to work remotely or on-site at client offices. However, candidates must be able to manage projects to completion within given timelines.

We regret that only qualified applicants will be contacted.