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Regulatory Affairs Manager | Pharma MNC (Pharmacist Only)

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HCLS/EP/RAM/130618C
Posted: 5 months ago
Consultant: Ewen Poh
Consultant Email: email Ewen
Consultant Phone: +65 6950 0365

Job description

Responsibilities

  • Lead country drug team for new product registrations, license extensions, variations, renewals according to agreed timeline, and ensure approvals in a timely manner

  • Develop and execute regulatory plans for new products and maintenance of licences/authorizations according to country business needs

  • Compile regulatory documents for submission according to local requirements

  • Review, edit and proofread regulatory documentation

  • Track status and progress of regulatory documentation

  • Assist in preparation, review and training if necessary of labelling, SOPs, and other departmental documents

  • Monitor applicable regulatory requirements; assure compliance with the company’s and external standards

  • Compile and prepare responses to regulatory authorities’ questions

  • Support the local manufacturing facility where necessary

  • Maintain regulatory files in a format consistent with requirements

  • Establish communication and good working relationships within RA, other functions and the health authorities

  • Maintain awareness of regulatory requirements

  • Participate as an active team member of regional project teams as required

 

Experience

  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with 3-4 years regulatory experience in a pharmaceutical and medical device regulatory affairs role and leadership experience preferred

  • Pharmacist license is a MUST

  • Strong verbal and written communication and presentation skills

  • Knowledge of regulations

  • Ability to independently identify compliance risks and escalate when necessary

  • Demonstrated interpersonal skills including strong negotiation skills

  • Scientific knowledge

  • Ability to manage complex projects and timelines in a matrix team environment

  • Ability to multitask and prioritize

  • Technical systems skills (e.g. word processing, spreadsheets, databases, online research)

  • Proofreading and editing skills

 

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.

 

This job has expired!