Pfizer Sr Executive Vacancy 2020 – Candidates Apply Online
Pfizer Vacancies – Pharma Vacancy. MPharma candidates are eligible to apply online for a Senior Executive vacancy at Pfizer. Pharma job opening 2020. Check out all the details on our website Rasayanika.com
Job Title: Sr Executive
What You Will Achieve
- You will represent Pfizer as an approval liaison in the regulatory affairs team and function as a Regulatory Strategist managing individual projects of benefit to therapeutic area teams within the group.
- You will play the critical role of supporting the GRLS who provides strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Your understanding of regulatory procedures will help in the development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
- As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
- It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Managing individual projects of benefit to therapeutic area teams within the group
- Day to day provision of general assistance to Strategists in the compilation of regulatory dossiers, coordination of marketing applications and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes
- Support for use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.
Specific
- Maintain Regulatory Product profile documents by updating as requested by strategist when key milestones occur. Including status of product indications supplement status per AG settlement
- Provide targeted documentation searches in GDMS in support of responding to Health Authority queries and/or internal queries (such as AG settlement information search or searches to support medical information responses)
- Support for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product) by preparing label comparison documents
- Complete data entry for PEARL updates as needed based on email template from PCOs
Prepare and manage viewpoint items for planned submissions as needed - Maintain tracking report for upcoming and pending approval submissions to facilitate communications with downstream team members such as Ad/Promo Regulatory, Commercial and PGS
- Prepare draft meeting notes and action item lists for Labeling and Rapid Response Team (RRT) meetings as needed
Qualifications
Must-Have
Education: Post Graduate in Pharmacy or Science.
Experience: Minimum 2 years of experience
Skills: Required – excellent written, listening and verbal communication skills, ability to problem solve, technical aptitude Ability to quickly learn and use new software, regulations and quality standards, attention to detail, ability to work independently with an appropriate level of supervision, experience in a customer service environment, aptitude in project management and logistics
Nice-to-Have
Knowledge of regulatory processes and documents, knowledge of therapeutic areas
Thinks strategically with good project management skills
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