Regulatory Affairs Specialist 2

1 week ago

Taguig, National Capital Region, Philippines Polytechnic University of the Philippines Full time

We are looking for an experienced Regulatory Affairs specialist with in-depth

knowledge of ASEAN Regulatory requirements in the Registration of pharmaceuticals, medical

devices, food supplements marketing authorization and licenses. Knowledge in implementation

of pharmaco-vigilance will be an advantage. Quality experience in interacting with Center for

Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) etc.

Duties and Responsibilities:

· You will be in-charge of all regulatory issues and affairs related to the company and

different regulatory bodies with respect to the products assigned under your

responsibility.

· Communicate and coordinate with all manufacturing partners/suppliers with based on

local FDA guidelines on product registrations or other pertinent issues as applicable.

· Coordinate and communicate with the concerned quality control and/or regulatory

officers of manufacturing partners/suppliers to ensure adherence to mutually acceptable

quality standards for the product as required to be complied by FDA Philippines

· Knowledge and skill in review of Product's Technical Dossiers (CTD) and other pertinent

documents and issues related to product registration with FDA Philippines.

· Proficiency in research and analysis for information and issues related to product

specific knowledge if necessary is expected.

· Create and maintain proactively an updated database of all product registrations and

licenses as necessary for renewals and submit the necessary requirements ahead of

time.

· Act as the authorized pharmacovigilance officer for the company by actively coordinating

the issues of product complaints/quality with the end-user and or regulatory authorities,

maintain updated log for submitted product complaints etc.

· Represent the company in various FDA sponsored activities, public hearings and

seminars as necessary.

Qualifications:

· Bachelor's degree in Pharmacy; advanced degree may be beneficial.

· Several years of experience in regulatory affairs, preferably in the relevant industry or a

related field.

· Excellent communication and interpersonal skills, with the ability to collaborate

effectively across departments and with external stakeholders.

· Detail-oriented with strong analytical and problem-solving skills.

· Ability to manage multiple projects simultaneously and prioritize tasks effectively.

· Ability to communicate and interact with different agencies and hospital accounts

· Knowledgeable on the process of inclusion and documentation in Philippine Hospitals

Nationwide

Requirements:

  • TOR or Diploma
  • Employment Certificate, if available
  • four copies of 1x1 and 2x2 white background picture
  • Birth Certificate or Passport
  • Valid NBI or Police Clearance
  • Tin Card or Tin Number
  • SSS Card or E1 form
  • Pagibig ID or Pagibig form
  • Marriage Certificate if applicable
  • Any two valid ID for opening of China Bank Payroll Account
  • Medical Examination with fit to work to be conducted by our accredited medical clinic

Skills:
(Not indicated)

Interested to apply? Send your application letter and CV to:

Names and logos are either trademarks or registeredtrademarks of their respective companies.

The PUP JobPOST is provided free of charge to PUPstudent and alumni job seekers. All hiring andcompensation for work performed by student employees ishandled directly between the student and the employer.The Career Development and Placement Office (CDPO) doesnot perform background checks on students applying forjobs, nor on employers posting job opportunities.Employers and students are encouraged to requestreference information from each other as needed toestablish qualifications, credentials and overall fitbetween the employer and the student applicant.

All job listings are posted at the discretion of theCDPO. We will not post jobs that appear to discriminateagainst applicants on the basis of race, color,religion, creed, age, national origin, veteran status,sexual orientation, disability, or gender. The CDPO alsoreserves the right to refuse to post jobs that do notsupport the interests of the University. The CDPO makesno particular recommendations regarding employers. Wemake no representations or guarantees about positionsposted by this office. We are not responsible forsafety, wages, working conditions, or any other aspectof off-campus employment.

Job listings are checked for their validity andaccuracy. However, given that situations change rapidlyin the marketplace, we do not and cannot guarantee thatopenings listed through PUP JobPOST will still exist, asposted, at the time of inquiry. CDPO makes norepresentation or guarantee about positions listed andis not responsible for safety, wages, working conditionsor other aspects of employment. It is each individual'sresponsibility to thoroughly research the integrity ofeach organization to which he or she is applying. Thestudent should take all care and use common sense andcaution when applying for or accepting any position

Students are urged to perform due diligence inresearching employers when applying for or acceptingprivate, off-campus employment. CDPO staff members areavailable for consultation on how to researchprospective employers.

For additional information regarding this disclaimer,contact the CDPO at or to 45 local 340.

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