Join Pfizer as a RAPD Associate II in Chennai, India
Pfizer, a global leader in the pharmaceutical industry, is urgently hiring for the position of RAPD Associate II at their Chennai, India location. This full-time role is critical in ensuring that Pfizer's medicines and vaccines reach patients swiftly and efficiently. The ideal candidate will possess a Bachelor's Degree and have experience in regulatory or drug development.
Why Patients Need You
At Pfizer, we are dedicated to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment demands forward-thinking and meticulous attention to detail. Your dedication and expertise will be instrumental in expanding and accelerating patient access to Pfizer medicines and vaccines.
What You Will Achieve
As a RAPD Associate II, you will represent Pfizer as an approval liaison within the regulatory affairs team. Your role will involve providing strategic product direction to teams, interacting with regulatory agencies, and negotiating to expedite the approval of pending registrations. You will be the regulatory liaison on project teams throughout the product lifecycle and a representative to marketing or research project teams and government regulatory agencies.
Key Responsibilities
- Project Completion: Contribute to the completion of project milestones and organize your work to meet project task deadlines.
- Team Compliance: Ensure team compliance with submission standards, procedures, and policies set by Global Regulatory Affairs.
- Document Preparation: Prepare and finalize Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements/variations for Lifecycle Management (LCM) submissions, ensuring effective data presentation and quality.
- Regulatory Support: Provide regulatory support to cross-functional teams for assigned products, participate in technical reviews, and strategic discussions on regulatory submissions.
- Promotional Materials: Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.
- Risk Management: Identify and assess regulatory risks associated with assigned projects and communicate timely to mitigate risks.
- Stakeholder Liaison: Liaise with key stakeholders to ensure filing strategies are defined and executed, meeting Board of Health (BoH) requirements, and ensuring a submission-ready dossier.
- Regulatory Databases: Maintain required regulatory databases to ensure compliance.
- Continuous Improvement: Manage continuous improvement of selected processes relating to Human health submissions and related activities.
- Timely Approvals: Ensure timely approval according to product registration plans.
- External Environment: Stay abreast of the external regulatory environment, including competitor intelligence, local product, and international regulatory and commercial strategies.
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RAPD Associate II at Pfizer in Chennai, India[/caption]
Qualifications
- Must-Have:
- Bachelor's Degree
- Proven ability to manage complex regulatory or drug development issues
- Knowledge of regulations and guidelines in various markets
- Strong relationships with local health agencies and other relevant stakeholders
- Excellent communication, collaboration, negotiation, and problem-solving skills
- Fluent in English, both written and spoken
- Computer literacy and ability to learn new systems
- Nice-to-Have:
- Knowledge of regulatory processes and documents
- Knowledge of therapeutic areas
- Strategic thinking with good project management skills
Work Location Assignment
- On Premise: This role requires you to work on-site at Pfizer's Chennai, India location.
How to Apply
For more details,
apply online
Equal Opportunity Employer
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
https://pharmastuff.org.in/job/rapd-associate-ii-pfizer-chennai
