Regulatory Affairs Manager | Pharma MNC (Pharmacist Only)

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.