Associate I – Reg CMC Strategy Full Time Part Time Jobs in Anna Salai, Chennai, Tamil Nadu @Pfizer
Job Types: Full-time, Part-time
Part-time hours: 48 per week
Full Job Description: Associate I – Reg CMC Strategy vacancy in Pfizer, Chennai
- 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.
- 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
- Knowledge of regulatory processes and documents, knowledge of therapeutic areas
- Thinks strategically with good project management skills
Work Location Assignment: Flexible