Job Purpose:
Regulatory Affairs Specialist 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.
Duties & Responsibilities:
- Obtain marketing authorizations and appropriate legal approvals.
- Maintain licenses for existing products.
- Prepare submission documents for new product registrations, renewals, and variations.
- Preparation of responses to requests by the Authority during the evaluation process, and timely handling of deficiency letters within the specific timeframe.
- Maintain a full up-to-date database and archiving system for tracking Regulatory dossiers.
- Ensure effective communication with the Regulatory Authority.
- Ensure company compliance with 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.
Qualifications:
- Bachelor's degree in pharmacy.
- At least 3-5 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.
- High organizational and communication skills
