Regulatory Affairs Section Head At GSK
Site Name: Egypt - Cairo
Act as a link between GSK and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local legislation.
Closely monitor and update regulatory environment by ensuring adequate regulatory intelligence communication to internal stakeholders.
Be aligned with the regulatory objectives on the needed actions and priority for each product based on local market and corporate strategy.
Responsible for the preparations and submissions of regulatory documents with the regulatory authorities to ensure the approval timing are not affecting the product supply.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed CMC changes or labelling changes.
Provide technical review of data that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Ensuring that quality standards are met, and submissions meet strict timelines.
Ensure that all registration files are consistent and matched with GSK values and expectations and MOH’s updated regulations and guidelines.
Recommend changes to company procedures in response to changes in regulations or standards.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Your Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Maintain licenses for GSK products (under license pharmaceutical products).
Seek approval for products’ CMC and clinical variations, according to GSK standards and MOH regulations while creating.
Prepare and submit the most updated leaflets for vaccines.
Maintain effective relationships with regulatory authority in Egypt.
Preparation, Submission and Follow-up of the re-registration files.
Preparation, Submission and Follow-up of the Stability files.
Preparation, Submission and Follow-up of analytical testing files.
Preparation, Submission and Follow-up of the scientific and labelling files.
Fulfilling all post approval commitments.
Follow up with GRA/GRPD/ Local sites/MSR teams’ variations and liaise the submission and follow up with MOH.
Maintain an up-to-date local regulatory archive for Egypt regulations (re-registration/variations/ labelling procedures, requirements, applications forms, fees & guidelines).
Develop and maintain a product database of all GSK portfolio and their status in Egypt (VeeVa, team sites, monthly reports).
Participate in internal or external audits preparation.
Attend F2F meetings with local sites for better follow up.
We are looking for professionals with these required skills to achieve our goals:
B.Sc. in Medicine, Pharmacy or Science
up to 6 years of experience.
Essential Skills and Abilities:
Good Interpersonal and negotiation skills
Communication and Public Relations skills
Good Command of the English Language
Good Microsoft office skills.
Planning and time management abilities