Regulatory Affairs Pharmacist

4 weeks ago

Manila, National Capital Region, Philippines Ambica International Corporation Full time

Job Description

Responsible for ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to the FDA to merit approval and secure a Certificate of Product Registration.

  • Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Food Initials, Medical Device Initials, and Cosmetic Notifications.
  • Responsible for renewal and revalidation of Principal Certificate of Product Registration and Certificate of Listing of Identical Product and ensure that the documents are overflowing with quality to secure the approval from FDA.
  • Communicates Equivalence Evidence Study with the supplier, evaluates, and prepares for submission.
  • Makes sure that the Bioequivalence Study Report meets the Criteria of ASEAN Guidelines, and Biowaiver Study/Comparative Dissolution Profile meets the WHO Guidelines.
  • Responsible for variation/amendment applications of Certificate of Listing of Identical Product and Principal Certificate of Product Registration.
  • Responsible for having follow-ups for the applications that were not yet evaluated by the FDA for timely release of approval from the FDA.
  • Prepares documents for PCPR and CLIDP Extensions.
  • Prepares documents for regulatory purposes/FDA concerns such as LTO application and LTO Renewal.
  • Evaluate the legal documents as per FDA requirements, to make sure that all Legal Agreements are valid upon submission to FDA.
  • Keeps up-to-date with changes in regulatory legislation and guidelines and disseminates the updates to the Regulatory Team.
  • Ensures that quality standards are met and submissions meet strict deadlines for the applications.
  • Responsible for GMP Clearance Applications and GMP Application Renewals. Ensures that GMP Evidence Dossiers for Non-PICs countries are well evaluated.
  • Ensures that the countries, specific fees for applications are paid on time.
  • Performs Quality Assurance on all artwork and ensures that labeling materials comply with FDA requirements and AO 2016-0008.
  • Attends to Medical Mission hosted by Ambica International Corporation.
  • Other duties as may be assigned by the management.

Job Qualification

  • Must be a licensed/registered Pharmacist.
  • Preferably with work experience in the field of Regulatory, but fresh graduates are welcome to apply.
  • Knows how to operate Microsoft Office (MS Word, Excel, Powerpoint, Outlook), and PDF (Nitro Pro, Adobe etc).
  • Good English communication skills is a must.
  • Able to type fast and accurately.
  • Can check documents for grammar, spelling, and punctuation errors.
  • Highly self-motivated, goal-oriented, and committed to pursuing a long-term career.
  • Exceptionally well organized and strong work ethic.
#J-18808-Ljbffr

  • Regulatory Pharmacist

    3 weeks ago

    Manila, National Capital Region, Philippines MARCBURG PHILIPPINES INC. Full time

    JOB QUALIFICATIONBachelor's Degree in PharmacyMust be a licensed PharmacistFresh Graduates are highly encouraged to apply, but experience as a regulatory pharmacist is an advantage.Knowledgeable in handling regulatory affairsFamiliar with FDA rulingHas good interpersonal skills and is attentive to details analyticallyCOMPANY BENEFITSMaxicare Healthcare...

  • Regulatory Affairs Expert

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    Job Summary:A leading pharmaceutical company seeks a highly experienced Regulatory Affairs professional to oversee the management of regulatory affairs for all products, ensuring compliance with statutory requirements and maximizing contributions to business objectives.About the Role:The ideal candidate will have a strong background in regulatory affairs,...

  • Regulatory Affairs Specialist

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    Job Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amb-HK Enterprises Inc.The ideal candidate will possess a Bachelor's/College Degree in Pharmacy, be a Licensed Pharmacist, and have at least 1 year of experience in regulatory affairs.Key Responsibilities:Review medical devices dossiers and documents according to...

  • Compliance Officer Regulatory Affairs

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    About the Role:This position requires a skilled Regulatory Affairs professional with experience working with regulatory authorities. The ideal candidate will have a degree in Pharmacy and be registered as a pharmacist in the Philippines. Fluency in English is essential, as is at least 2-3 years of experience in Regulatory Affairs. Direct experience of...

  • Pharmaceutical Regulatory Affairs Manager

    2 weeks ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    We are seeking a highly skilled Regulatory Pharmacist to join our team. In this role, you will be responsible for ensuring that our products remain compliant with regulatory requirements. Your key responsibilities will include:ResponsibilitiesAcquire and Maintain Product Registrations: You will be responsible for acquiring and maintaining product...

  • Compliance and Regulatory Strategist

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    Job Overview:A global pharmaceutical leader is seeking an experienced Regulatory Affairs professional to join their team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maximize business contributions. This is an exciting opportunity to leverage your expertise and...

  • Regulatory Affairs Lead

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    The Pharmaceutical Regulatory Affairs Director will oversee regulatory compliance across pharmaceutical operations.Develop and implement effective regulatory strategies and policies.Lead communications with regulatory authorities on critical matters.Collaborate across functions to ensure regulatory alignment in business decisions.Lead, mentor, and develop a...

  • Regulatory Affairs Strategist

    2 weeks ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    We are seeking a highly skilled Regulatory Affairs Strategist to join our team. As a key member of our regulatory affairs department, you will play a critical role in supporting and leading regulatory compliance processes and innovation projects.The ideal candidate will have a strong understanding of post-marketing commitments, health authority queries, drug...

  • Regulatory Affairs Expert

    1 week ago

    Manila, National Capital Region, Philippines beBee Careers Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our Global Regulatory Strategic Compliance (GRSC) team, you will play a critical role in ensuring effective execution of regulatory strategies and compliance processes.Key ResponsibilitiesLead Post Marketing Commitment (PMC), Health Authority Queries...

  • Regulatory Affairs

    4 weeks ago

    Manila, National Capital Region, Philippines Manpower Philippines Full time

    The Regulatory Affairs & QA Specialist is responsible for assistance and support in ensuring the Company's consistent compliance with Company and Philippine government and corporate standard regulatory and QA compliance.Regulatory AffairsMaintains good and harmonious professional relationship with government regulatory agencies.Secures the required documents...