Regulatory Affairs Manager
Kuala Lumpur, Malaysia
Job posting number: #7150688 (Ref:pf-4885975)
Posted: May 26, 2023
Application Deadline: Open Until Filled
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 a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Manage multiple projects/ ongoing work activities within the department typically involving cross-functional representatives.
Provides technical, functional guidance and oversight to team members within the department.
Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil local regulatory standards.
Ensure local licenses under country responsibility are maintained in compliance with local regulations and following corporate policies, regulatory processes, and Standard Operating Procedures (SOP).
Work with Global Product Owners and cross functional team to ensure preparation and submission of Global Annual Reports (AR) for NDAs & ANDAs(Abbreviated New Drug Application).
Act as the Regulatory Lead for Life Cycle management (LCM) and work with regulatory strategist and cross functional teams to ensure preparation of quality global regulatory strategy document and supplements/variations.
Update the assigned local product documents in consistency with the local regulations and in the related systems.
Manage and oversee all relevant maintenance activities potentially including Life Cycle management strategy.
Identify and assesses regulatory risks associated with assigned projects and timely communication to the leadership team to quickly mitigate the risks.
Drive resolution of identified issues by communicating issue, impact and outcomes to global regulatory management and core team.
Negotiate with and influences management , cross functional teams and colleagues to ensure project timelines and quality expectations are met.
Manage the budget and resources allocated to the Regulatory Teams.
Set objectives and manage team performance to achieve best outcomes for business, ensure right training and upskill plans for team.
Bachelor's Degree (BA/BS) and 5+ years of experience.
Demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission, and maintenance.
Strong analytical skill and technical/ scientific competence.
Good oral and written communication skills.
Analytical problem solving skills.
Good decision making skills.
People management experience.
Master's degree (MA/MBA/MS) and 3+ years of experience.
Knowledge pharmaceutical legislation in region.
Good business acumen.
Working knowledge of Local and International Regulatory Guidelines.
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
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.