Regulatory Affairs Section Head
Cairo, Egypt
Job Description
Site Name: Egypt - Cairo
Posted Date: Jul 29 2022
Job Purpose
Contact information:
You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Posted Date: Jul 29 2022
Job Purpose
- 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.
- 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.
- B.Sc. in Medicine, Pharmacy or Science
- up to 6 years of experience.
- 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
Contact information:
You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Beware of fraud agents! do not pay money to get a job
MNCJobsGulf.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.
Related Jobs
Job Detail
-
Job IdJD1422965
-
IndustryNot mentioned
-
Total Positions1
-
Job Type:Full Time
-
Salary:Not mentioned
-
Employment StatusPermanent
-
Job LocationCairo, Egypt
-
EducationNot mentioned