Job Description

Purpose of job/position

The Regulatory Affairs Head manages the process for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general products life cycle management including pro-brand strategies.

Also, is responsible for developing submission strategies; providing guidance/advice on local country regulatory environments; providing assessment of the impact of new and changing regulations/requirements. Keep strong relationship with key external stakeholders such as BoH and industry associations.

Accountabilities

• Evaluate local business and regulatory registration requirements for investigational and marketed products, prepare regulatory assessment reports.
• Develop submission strategies; prepare project plans, timeslines and related project fees. Prepare project status repor...