Senior Specialist, Regulatory Affairs

Description:

Responsible for performing Regulatory Affairs 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:

1. Coordinates all regulatory activities for submissions throughout the regulatory life cycle from preparation, submission, deficiency letters to approvals and variations to ensure efficiency in execution for each step.
2. Implements regulatory plans for the submission of new products and maintenance activities for existing products to meet department plans.
3. Requests, gathers and performs a technical critical evaluation of the essential documentation to identify what is needed for the submissions.
4. Informs the site about the regulatory actions to perform follow ups until approval of dossier, deficiency letter or supplement/variations.
5. Prepares, coordinates and follows up the renewal processes/annual report to comply with the department objectives and ensure deadlines are fulfilled.
6. Monitors the life cycle of approved dossier to ensure it is kept up to date.
7. Updates all internal control tables and maintains visibility of the documents including all submissions and approvals to align with internal SOPs.
8. Provides regulatory advice to assist teams and give updates at staff meetings.
9. Maintains awareness of applicable regulations and guidance to keep up to date with the relevant guidelines and information that could impact the regulatory projects.
10. Coordinates and follows-up with cross functional departments to ensure that submission documents are available in time to meet submission timelines and to ensure that documents meet the authority guidelines and standards.
11. Trains and guides newly hired resources on all relevant regulatory guidelines and procedures to ensure they are well equipped to perform their tasks efficiently
12. 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 4-6 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.
• Fluency in English, both written and verbal