Pfizer Off Campus Recruitment Drive 2022 |
Hiring Freshers for the role of Interns for Chennai Location
Intern
Locations: India - Chennai
time type: Full time
job requisition id: 4871896
Why Patients Need You
We're looking to bring
medicines to the world faster and we are not willing to compromise on
excellence and integrity. Adhering to local and global regulations is essential
and the ever-changing regulatory environment requires forward thinking and
attention to detail. Your dedication and expertise will help expand and
accelerate patient access to Pfizer medicines and vaccines.
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What You Will Achieve
You will represent Pfizer as an
approval liaison in the regulatory affairs team. You will play the critical
role of providing strategic product direction to teams while interacting with
regulatory agencies and negotiating with them to expedite approval of pending
registrations. Due to your expertise, you will be the regulatory liaison on the
project team throughout the product lifecycle and a regulatory representative
to marketing or research project teams and government regulatory agencies. Your
understanding of regulatory procedures will help in development of submission
of product registration, progress reports, supplements, amendments and periodic
experience reports.
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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
- Contribute to the completion of project
milestones and organize own work to meet project task deadlines.
- Ensure compliance of the team to the submission
standards, procedures and policies framed by Global Regulatory Affairs.
- Responsible for the preparation and
finalization of Global Regulatory Strategy Documents (GRSD), Comparative
Toxicogenomics Database (CTD) sections of supplements / variations for
Lifecycle Management (LCM) submissions and ensure effective data
presentation and quality, by self or under guidance.
- Provide regulatory support to the cross
functional teams for the assigned products, participates and provides
inputs in technical reviews and strategic discussions on regulatory
submissions.
- Provide regulatory inputs for the approval of
promotional materials following applicable regulatory requirement, Pfizer
policies, procedures, and practices.
- Identify and assess regulatory risks associated
with assigned projects and timely communication to the team to quickly
mitigate the risks.
- Liaise with key stakeholders to ensure the
filing strategies are defined and executed, and Board of Health (BoH)
requirements are met, ensuring a submission ready dossier.
- Ensure commitments made to health authorities
are entered into tracking systems and are tracked to closure.
- Manage continuous improvement of selected
processes relating to Human health submissions and selected drug and
non-drug specific projects and related activities.
- Ensure timely approval according to product
registration plan.
- Maintain the required regulatory databases to
ensure compliance.
- Keep abreast of the external regulatory
environment, including competitor intelligence, local product and
international regulatory and commercial strategies.
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Qualifications
Must-Have
- Bachelor's Degree
- Proven ability to manage complex regulatory or
drug development issues
- Knowledge of the regulations and guidelines in
the various markets
- Strong relationship with the local health
agency and other relevant stakeholders and pro-actively manages issues
with key external stakeholders
- Good skills on communication, collaboration,
negotiation and problem solving
- Fluent in English, written and spoken
- Computer literacy and ability to learn new
systems
Nice-to-Have
- Knowledge of regulatory processes and
documents, knowledge of therapeutic areas
- Thinks strategically with good project
management skills
Work Location Assignment: On Premise
Pfizer is an equal opportunity
employer and complies with all applicable equal employment opportunity
legislation in each jurisdiction in which it operates.
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