Associate Ii, Reg Cmc Strategy, Si Lcm
4 weeks ago
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.
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.
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.
**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: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
LI-PFE
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