CIELO TALENT PTE. LTD.
CIELO TALENT PTE. LTD.

Cielo is the world’s leading provider of global talent acquisition and management solutions. In May 2014, the company rebranded to reflect the successful integration of U.S.-based Pinstripe, Inc. and UK-based Ochre House, which combined to become the largest independent provider of strategic recruitment process outsourcing (RPO), search solutions and talent consulting services worldwide.

Cielo leverages its global scale, customized, innovative solutions and entrepreneurial agility to help clients achieve sustained people advantage and outstanding business outcomes. Through world-class, technology-enabled solutions, Cielo serves clients primarily in the financial and business services, consumer brands, technology and media, engineering, life sciences and healthcare industries.

Cielo’s global presence includes nearly 1,000 employees, serving more than 90 clients across 57 countries in 26 languages. This footprint includes Moorland Gray, the largest and most successful executive search firm in the Middle East and North Africa. Cielo knows talent is rising – and with it, an organization's opportunity to rise above.

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Asia Head, Regulatory Affairs

  Company :     Working Hours :  

  Job Type :  

Full Time

  Salary :  

$14,000 - $25,000 / monthly



Job Description

JOB PURPOSE:

Head of Asia Zone will have a strong oversight of regulatory activities in Asia countries and be Genmed Business Partner.  He/She will collaborate with International Country Management, Regulatory Transformation, International Product Lead.  Asia Country RA heads will report into Asia Zone Head.


KEY ACCOUNTABILITIES:

  • Work in collaboration with International PLs and Asia RA head for development of regional product and labeling submission strategy People and talent management
  • Provide Regulatory input to Global Regulatory Affairs on local RA strategy, liaise with Commercial Ensure adequate process flow for the dossiers to support regional business goals, optimum yearly targets and registration plans. Interact with and support BU management, sales & medico-marketing group for the preparation of market plans and direction to be undertaken by HQ. 
  • Become an expert of Asia regulatory requirements and provide clear guidance to company stakeholders related to any potential impact on product registration and maintenance. 
  • Coordination of regulatory activities between source contact & RA Affiliates to ensure availability of the dossier / additional data and find appropriate ways to facilitate and accelerate product registration. 
  • Clear updates to International Region Head of Regulatory risks, opportunities and internal/external emerging topics.  
  • In collaboration with International CMO, ensure appropriate planning and tracking of submissions by RA Affiliates / estimated & effective approval dates
  • Support development and implementation of standard operating procedures and systems and tools related to regulatory affairs Provide Regulatory expertise on external growth opportunities (DD) and for each project ensure adequate regulatory resources for dossier assessment, coordinate regulatory activities with RA Affiliates, source contact and other relevant functions.
  • Identify regulatory issues and ensure resolution in a timely fashion with adequate planning. 
  • Provide effective communication to functional, regional organizations and project team members. Identify and work closely with internal and external experts to achieve optimal outcomes. 
  • Develop strong partnership with other departments, i.e.:  Public Affairs, Industrial Affairs, BD,
  • Legal, Finance, Medical, Pharmacovigilance, supply chain, marketing, etc.


JOB-HOLDER REQUIREMENTS:

Education:  Degree in Pharmaceutical Sciences/ Life Sciences/ Bio-medical sciences (Candidates with Bachelor’s degree in the other disciplines may also be considered provided they have relevant working experience)


Experience & knowledge:

Essential:

  • At least 5 years of experience including internships in regulatory CMC/ Regulatory affairs in regulated or lesser regulated markets.
  • Highly self-motivated,  Pro-active, responsible and autonomy.
  • Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
  • Well-organised with good sense of responsibility.
  • Computer skills: Word, Excel, On-line (Quest 2) Registration.
  • Wide exposure of transversal work with colleagues from different function ie. Regulatory and non-regulatory organisation (PV, medical, commercial, business development, supply chain etc)

Desirable:

  • Prior experience in Asia regulatory affairs would be an advantage.
  • High influencing skills
  • Strong organizational and negotiation skills

Core competencies /skills:

Essential:

•       Ability to work in a matrix organization.

•       Good team spirit and familiar with project development through cross-functional activities.

•       Ability to establish and maintain good regulatory networking internally and externally.

•       Solution oriented, talent management

Desirable:

•   Good networking at the regulatory level both within the company and with the governmental bodies.

•   Flexible mindset is a key ingredient for success in the regulatory space.

•   Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing in each country.

•   Process oriented and very good at data management as this will be the single point of contact for the region.

•   Capable of interacting with the other regional platforms of Europe and ITC


Act for Change / Cooperate Transversally / Strive for Results / Commitment to Customer / Think Strategically / Make Decisions  / Teamwork ability: good interpersonal & communication skills / Ability to work in a matrix organization / Business and customer orientation / Networking and influencing skills/ Strong organizational and leadership skills/ Strong Project Management skills/ Strong cultural awareness


Language:

Fluent in English

Good level of reading, spoken and written competency in 1 or more languages (other than English) would be an added advantage

 Location: 38 Beach Road 189767.  How to get there?

 Location: 38 Beach Road 189767.




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