Regulatory Affairs Executive

Regulatory Support
- Support the Head of Regulatory Affairs (HRA) to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with company’s strategic objectives.
- Support HRA with coordination of projects with regulatory implications, including product registration strategies for new products, new indications or formulations within Singapore.
- Support expediting product commercialization by ensuring that Singapore’s registration requirements are fulfilled, and registration approvals are obtained as quickly as possible.
- Review, analyze and coordinate data and provide feedback to HRA for new product submissions, line extensions, variations to marketed products, responses to deficiency letters, when required.
- Work in close collaboration with other regulatory counterparts within the Commercial organization to ensure the efficient and consistent execution of strategic regulatory plans across Pfizer’s portfolio and be accountable for regulatory compliance within the area of responsibilities.
- Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications under close supervision of HRA.
- Support activities related to product license maintenance and resolution of relevant regulatory issues.
- Support resolution of production and manufacturing issues, such as submission/negotiation strategy, sourcing issues, packaging issues, and compliance matters.
- Support the maintenance of the Global Regulatory System and ensures timely updates.

Communication
- Ensure effective communication with colleagues within Commercial, WRS, PGS and SCMQO on matters of mutual interest.
- Interact and participate in negotiation discussions on regulatory matters concerning Pfizer’s portfolio with Regulatory Authorities and industry associations (e.g. Singapore Association of Pharmaceutical Industry SAPI), as appropriate.
- Monitor, analyze, interpret and inform HRA regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment/climate issues, regulation and external meetings concerning regulatory matters.
- Support HRA to anticipate changes in country registration policies and guidelines and keeps relevant Pfizer groups informed of changes in the regulatory environment.
- Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.
- Monitor and consult HRA for dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Pfizer products.

Inventory Support
- Support HRA in coordinating with inventory function and PGS, to ensure stock availability to local market, while strategically planning the timing to ensure stocks availability for new product launches.

Marketing Support
- Support the development of promotional materials that are in keeping with Pfizer’s standards by providing latest labelling information and strategizing product labelling to Pfizer’s benefit.

**Qualifications**:

- Bachelor degree in Science or Pharmacy
- Good knowledge of international or local regulatory guidelines and codes
- 1 year of working experience in a regulatory affairs environment
- Fresh graduates are encourage to apply
- Knowledge of HSA guidelines
- Knowledge of therapeutic areas preferred
- Meticulous nature and proficient in data tracking and consolidation with Microsoft Excel
- Provide regulatory input to HRA to support marketing plans, product launches and other cross-functional activities.

Regulatory Compliance
- Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, international regulations and Pfizer SOPs.
- Support HRA to ensure registered products are maintained in full compliance with all relevant legislation and PGP procedures.
- Coordinate with HRA on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Health authority.

Work Location Assignment: Flexible

LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs