Regulatory Affairs Supervisor At Hikma Pharmaceuticals
Regulatory Affairs Supervisor is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations.
Secure obtaining marketing authorizations of new launches in line with the company’s plans and goals.
Secure the submission and approval of renewals for products portfolio on timely manner to maintain licenses for existing products.
Secure the submission and approval of variations for products portfolio on timely manner.
Ensure preparation of submission documents for new product registrations, renewals, and variations.
Ensure preparation of responses to requests by the Authority during the evaluation process, and timely handle deficiency letters within a specific timeframe.
Ensure implementation of the regulatory plans in a timely and accurate manner.
Create and maintain a full up-to-date database and archiving system for tracking Regulatory dossiers.
Ensure effective communication with the Regulatory Authority.
Ensure company compliance to regulatory regulations.
Follow up and implement any updates on the regulatory regulations and guidelines, keeping all relevant stakeholders timely and pro-actively updated.
Effective communication and cross-functional interaction with all involved departments, both on a Regional and Central level (Regulatory Affairs, Quality Assurance, Quality Control, Production, Supply chain, Sales and Marketing and Pharmacovigilance) to facilitate and develop effective collaboration on all regulatory interactions.
Bachelor degree in Pharmacy.
At least 6-8 years professional experience in Regulatory Affairs.
Good understanding of Regulations.
Knowledge of the structure and the specifics of formation and functioning of the dossier in CTD/eCTD formats.
High English proficiency.