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Regulatory Affairs Manager

Job Category:

Administration / Corporate Services

Job Level:

Professional

Open Date:

06-Jul-2020

Location:

TAGUIG CITY

Close date:

31-Aug-2020

Client Industry:

PHARMACEUTICAL

Job Description and Qualification:

Job Description

  • Reports to Clinical, Medical and Regulatory Head
  • Main responsible person for NNPPI regulatory affairs function and principal contact person to the Philippine FDA
  • Manage regulatory operations in the Philippine affiliate
  • Maintenance of the PhFDA license to operate for drugs and medical devices
  • Life-cycle management of the product’s marketing authorization
  • Secure timely approvals of new drug or device applications, regulatory intelligence
  • Provide regulatory support to different departments/teams within the affiliate that is aligned with the local business demands
  • Protect and maintain the affiliate’s license to operate for drug products and medical devices
  • Coordinate and supervise RA applications related to life-cycle management
  • Coordinate and supervise RA applications related to new drug applications
  • Develop affiliate level regulatory strategy and implementation plans
  • Review and approval materials in Veeva
  • Provide regulatory support and insights to internal and external stakeholders
  • Monitor the local regulatory environment, regulations and requirements
  • Review, evaluation and approval of grants, donations and support (GDS) as a member of the GDS committee
  • Develop the overall regulatory strategy for NNPPI which is linked to the overall affiliate strategy
  • Provide input to regulatory implementation plans and product information
  • Provide input to affiliate launch plans and conduct effective cross-functional collaboration in other related promotional activities
  • Plan and prepare the regulatory fees and budget
  • Monthly update and reporting on the RA Submission Plan to the affiliate management team
  • Monthly update and reporting on the regulatory status to BASEA RA
  • Provide accurate and relevant internal regulatory advice
  • Collaborate, coordinate and negotiate with the RA Teams from HQ, APAC, and BASEA to align with the overall regulatory directions and priorities
  • Responsible for updating the company with current internal requirements and external guidelines and legislation within the area of responsibility of regulatory affairs
  • Deliver plans and initiatives on new regulatory legislation
  • Provide competitor monitoring of marketing authorizations to affiliate stakeholders and BASEA RA
  • Closely monitor upcoming legislations within the scope of regulatory affairs
  • Provide trends with accompanying recommendations in regulatory affairs in the Philippines
  • Provide guidance to the affiliate regarding local regulations, policies and requirements

Qualifications

  • University degree (BS Industrial Pharmacy or BS Pharmacy)
  • Licensed Pharmacist with the Philippine Professional Regulation Commission
  • Accredited by PhFDA as Qualified Person in Industry Regulatory Affairs (QPIRA)
  • Attendance to PhFDA Academy trainings on: QPIRA, licensing and pharmacovigilance
  • Fluent in oral and written English
  • Must have at least 6 years of working experience in regulatory affairs experience required
  • Advanced knowledge of pertinent local regulations required
  • Experience with regulatory intelligence activities and pharmaceutical registration databases is required
  • Knowledge and experience in handling biological, pharmaceutical and medical device marketing authorizations and licenses
  • Knowledge in local regulatory requirements on Pharmacovigilance, Quality Assurance and GxP
  • Knowledge of diabetes and diabetes management is beneficial
  • Prior interaction and exposure with the Philippine FDA
  • Ethical liaison with regulatory authorities
  • Previous management experience required depending on team size


Salary:

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