Contract Regional Regulatory Affairs (Pharma) Manager - Starts June!

Recruit Express Pte Ltd

Contract Regional Regulatory Affairs (Pharma) Manager - Starts June!

Recruit Express Pte Ltd


Job Nature: Contract

Position Level: Experienced, Manager

Job Category: Medical/Life Science, Sciences

Qualification: Bachelor's / Honours

Salary: Login to view


  • Gain and maintain regulatory approvals to allow product supply and ensure compliance within the ASEAN affiliate (Brunei, Hong Kong, Macau, Malaysia, Singapore, Thailand).
  • Consolidate all the ASEAN countries requirements for more efficient submission process in the multiple ASEAN countries.
  • Contribute to the submission strategy for product/indication registrations in ASEAN.
  • Support the execution of competitive regulatory strategies for development of existing projects in order to shorten development time and obtain the most favorable outcome; including new molecular entities, biologics, parenteral formulations and combination products.
  • Maintain focus on corporate goals while responding to the needs of product development and project in a flexible manner (e.g. immediate response to shifting project priorities and ability to adapt quickly to evolving situations).
  • Prepare local submission packages for NDA applications, indication extension submissions, maintenance of licenses (including variations, license renewals, post-marketing commitments follow-ups, labelling revisions, preparation of responses to questions received from health authorities etc).
  • Work with Global Regulatory Affairs to obtain all registration documents for local submissions and to formulate appropriate responses to questions from health authorities.
  • Provide regulatory documentation support where needed (e.g. hospital listing, NPP application etc).
  • Review and approve clinical trial label text.
  • Support the promotional materials review processes in ASEAN.
  • Collaborate closely with various cross functions in the preparation of product launches.
  • Provide timelines and related information to Product Lifecycle Management, Supply Chain, Quality Assurance for planning and implementation of labelling and packaging changes.
  • Management of Dear Healthcare Professional communication and working cross functionally with sales force on distribution.
  • Support regional QA/RA/RMP/PV audits and CAPAs as necessary.
  • Support the transitioning and managing of partner Regulatory Affairs service providers.
  • Support the re-modelling of Pregnancy Prevention Programme in ASEAN.
  • Represent Regulatory Affairs department in assigned project meetings and effectively communicate program development to senior regulatory management.
  • Ensure project teams prepare high quality international filings/registrations and responses to Agency requests within established timelines.
  • Responsible for management of regulatory reporting activities, including but not limited to: annual report, 4-monthly sales and importation report, PSUR submissions etc.
  • Maintain up-to-date knowledge on regulatory requirements for the ASEAN region.
  • Review departmental and interdisciplinary standard operating procedures and assist in the design of departmental policies; adherence to all of the above.
  • Maintain regulatory systems and databases to support effective implementation of regulatory activities, so as to ensure timely registrations/variations and renewals of products.

 

Job Requirement:

  • Bachelor’s Degree in Pharmacy, or equivalent, minimum 4 years of Regulatory Affairs experience dealing with innovative products, including drugs for hematology and oncology is preferred.
  • Good working knowledge of drug approval process.
  • Must be able to respond flexibly to changing project priorities and work assignments.
  • Must be able to work independently and to identify, recommend solutions to problems.
  • Must be able to work in an environment where individual initiative and accountability to the team are required.
  • Familiarity with Microsoft Word and PowerPoint; ability to work both independently and within a team structure.

Interested candidates please submit your resume to [Click Here to Email Your Resume] 

Alternatively, pls call Jace at 6736 3280

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

Company Overview

 
Singapore’s Largest & Most Preferred Recruitment Company!
As a premier leading recruitment consultancy in Singapore, our success has been a result of our focus in facilitating the success of our Clients in business whilst enhancing the career opportunities for our Candidates.

With our swift expansion across the region, we now have offices in Singapore, Taiwan, Sydney, Kuala Lumpur and Hongkong as well as a partner network in Shanghai and Japan.

We serve with distinction and provide comprehensive staffing needs. As the total recruitment and staffing solutions partner, our goal is to provide our Clients the best staffing solutions through an integrated database network supported by localized content and services.

EA Licence No.: 99C4599
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