Senior Regulatory Affairs Manager

1 week ago

Taguig, National Capital Region, Philippines YS Biopharma (Philippines) Inc Full time

Pharmaceuticals & Medical Devices (Healthcare & Medical)

  • Develop and implement regulatory strategies to facilitate the approval, registration and commercialization of vaccine products in compliance with applicable regulatory requirements
  • Have strong knowledge of the regulatory requirements and registration pathways for vaccines and biologics initially for countries in Asia and moving on to the rest of the world
  • Assess regulatory risks, evaluate regulatory pathways, and advise senior management on strategies to achieve regulatory objectives while minimizing delays and obstacles
  • Prepare, review, and submit regulatory documents, applications, and dossiers to regulatory agencies for product approvals, registrations, and licenses
  • Maintain regulatory compliance throughout the product lifecycle by monitoring changes in regulations, assessing the impact on products, and implementing necessary updates and modifications to maintain compliance.
  • Serve as the primary point of contact for communication and interaction with regulatory agencies, such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other governmental bodies.
  • Represent the company in regulatory meetings, discussions, and negotiations, and provide responses to regulatory inquiries, requests for information, and deficiency letters to address regulatory concerns and facilitate approvals.
  • Collaborate with cross-functional teams within the organization, including pre-clinical research and development (R&D), Clinical Development and Operations, quality assurance, manufacturing, marketing, and legal department to ensure alignment and coordination on regulatory matters.
  • Provide regulatory guidance and support to internal stakeholders, participate in product development team meetings and facilitate communication and collaboration to achieve regulatory objectives and timelines
  • Drive compliance to regulations and develop internal regulatory standards & processes (SOPs)
  • Responsible to prepare, hold and lead cross-functional team meetings, take a leadership role on assigned projects and initiate & lead various projects.
  • Responsible to define the need for and to organize, request and track orders for registration samples, working with Regional and local regulatory affiliates and Global Supply Chain personnel.
  • Provide training and education to internal stakeholders on regulatory requirements, processes, and best practices to promote awareness and understanding of regulatory compliance obligations
  • Conduct regulatory intelligence activities, such as analysing regulatory trends, attending industry conferences, and participating in regulatory forums and working groups, to stay informed and advocate for the company's interests with regulatory authorities and industry associations

Qualifications:

  • Bachelor's degree in a relevant scientific field such as Pharmacy, Chemistry, Biology, or related disciplines. Advanced degrees (e.g., Master's or Ph.D.) are often preferred.
  • 5-10 years of experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, or related industries. Experience in both early-stage and commercial-stage products is valuable.
  • In-depth understanding of global regulatory requirements and guidelines, including FDA, EMA, PMDA, and other regulatory agencies.
  • Demonstrate leadership skills, including the ability to influence and collaborate across functions and geographies.
  • Professional certifications such as RAC (Regulatory Affairs Certification) are often preferred or required.
  • Experience speaking at external meetings and acting as a company representative on pharmaceutical industry meetings is highly desirable.
  • Fluent in written and spoken English. Knowledge of Mandarin is a plus factor
Your application will include the following questions:

How many years' experience do you have as a Regulatory Affairs Manager?

How much notice are you required to give your current employer?

Are you willing to undergo a pre-employment background check?

Are you willing to relocate for this role?

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