- Writing and submission of registration documents for medicinal product and Medical Device (New Submission, life cycle management and labeling)
Quality review in CTD / eCTD format as per EU/USFDA guidelines.
Preparation of query responses and variation to the concerned health authorities
Qualification and Compliance of suppliers (including contract manufacturers)
Responsible for regulatory strategies for new submission and for registered products.
Close cooperation with the suppliers and international partners
- Degree in Pharmacy or natural science
Min. 2 year of experience in field of Regulatory Affair
Ability to work both independently and within a team structure and should have good computer skill.
Strong planning, presentation and interpersonal skills.
Strong work ethic, self-motivation, dedication, results oriented.
Should be fluent in English. Knowledge of Arabic language will be an additional advantage.
Recruiter Name:Mr. Alam Shahnwaj
Email Address:
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