Jobs Career Advice Signup
X

Send this job to a friend

X

Did you notice an error or suspect this job is scam? Tell us.

  • Posted: Jun 2, 2021
    Deadline: Not specified
    • @gmail.com
    • @yahoo.com
    • @outlook.com
  • Pfizer South Africa’s vision of "living our full potential in striving for a healthier Southern Africa" forms part of Pfizer’s ethos whereby every Southern African should have access to quality healthcare. At Pfizer South Africa we are dedicated to the improvement of human life and the battle against disease & disability. We have...
    Read more about this company

     

    Regulatory Affairs Pharmacist/Specialist (Contract position)

    About Job

    Summary: Support the local and regional regulatory organization in the development, execution and implementation of country-specific regulatory strategies to support the approval and registration of clinical trial applications (as applicable), new products, line extensions, major variations and lifecycle management.

    • Develop strong cross-functional partnerships with in-country and above-country colleagues to effectively execute registration strategies for new and existing product portfolios.
    • Responsible for developing, enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs). 
    • Understand local regulations and developing trends in the local regulatory environment.  Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
    • Liaise with clinical research project managers to seek to understand clinical research programmes as required. 
    • In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries as required.
    • Ensure timely communication of any GCP breaches, or actions taken for safety reasons as required.
    • Compile and submit clinical trial applications (as applicable), new product applications, generic applications, new indication or line extension applications to the relevant HA’s/BoH’s, ensuring that registration requirements are fulfilled.
    • Responsible for the co-ordination of regulatory activities associated with product approval, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of regulatory submissions at the HA.
    • Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations and ensuring that corporate regulatory processes, SOP’s and systems are followed.
    • Maintain compliance in company-specific regulatory systems,databases and local regulatory drive to ensure a state of audit readiness.
    • Maintain compliance of local product artwork and promotional materials in line with local legislation, regulations and company standards
    • Review of dossiers and sign as pharmacist in the event that HRA, Southern Africa is not available for an extended period
    • Participate in internal audits as required.
    • Represent the regulatory team at product specific cross-functional team meetings.
    • Where required, represent company at the relevant industry trade association meetings.

    Education:

    • Bachelor of Science degree or Bachelor of Pharmacy degree 
    • Minimum of 4 years’ experience in Regulatory Affairs, preferably in human medicines
    • Demonstrable experience across the product development, commercialization and maintenance lifecycle
    • Proven ability to manage complex regulatory issues
    • Proven ability to consistently deliver to time, cost and quality standards

    Technical skills:

    • In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.
    • Knowledge of clinical trial methodologies ICH/GCP, FDA and local country regulations whilst useful is not critical.
    • Knowledge of clinical trial and regulatory requirements as pertaining to human medicines as required.
    • Knowledge of the Marketing Code of Practice

    Behavioural Skills

    • Strategic thinker
    • Strong communication skills
    • Negotiation skills
    • Problem-solving abilities
    • Strong detail, quality and compliance orientation
    • Ability to understand stakeholder needs
    • Building strong peer relationships
    • Team player
    • Interpersonal acumen
    • ‘Big-picture’ thinking
    • Analytical thinking
    • Change agility/adaptability

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

    Method of Application

    Interested and qualified? Go to Pfizer on pfizer.wd1.myworkdayjobs.com to apply

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

  • Send your application

    View All Vacancies at Pfizer Back To Home
Average Salary at Pfizer
R 221K from 5 employees
Mysalaryscale.com

Career Advice

INTO banner
View All Career Advice
 

Subscribe to Job Alert

 

Join our happy subscribers

 
 
 
Send your application through

YahoomailYahoomail GmailGmail Hotmail Hotmail