Job Title: Intern
Salary Package: Up to 4LPA
Company Name: Pfizer
Job Location: Chennai, Tamil Nadu, India
Qualification: Any Graduate
Job Info:
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.
Required Qualifications & Skills:-
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 in 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
Job Responsibilities:-
As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
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 ensuring effective data presentation and quality, by self or under guidance.
Provide regulatory support to the cross-functional teams for the assigned products, participate and provide inputs in technical reviews and strategic discussions on regulatory submissions.
Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.
Identify and assess regulatory risks associated with assigned projects and timely communicate 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 the product registration plan.
Maintain the required regulatory databases to ensure compliance.
Keep abreast of the external regulatory environment, including competitor intelligence, local products and international regulatory and commercial strategies.
Apply In the Below Link
Note:– Only shortlisted candidates will receive the call letter for further rounds.