Regulatory Affairs Specialist

Regulatory Project Specialist

Pharmaceutical Industry - Pfizer

1 year Contract (renewable basis)

Bangsar, Kuala Lumpur

Mon - Fri (9am - 6pm)

Salary : RM RM benefit +  1 month bonus

NOTE :

• Experience in Regulatory Operation and submission for NPRA, an advantage if they have done submissions for Southeast Asia countries.
• Understand end-to-end submission for NPRA,

Summary :

The Regulatory Project Specialist is mainly responsible for regulatory affairs support related to new and in-line products within the country. The activities encompass regulatory submissions to the authorities for marketing authorization transfer, new product registration, variations, and miscellaneous application such as ad-hoc requests and permits, special exemption when required, and general product maintenance.

The Regulatory Project Specialist is expected to support expediting product commercialization by ensuring that local registration requirements are fulfilled and registration approvals are obtained in the shortest possible time.

Duties :

Regulatory Support

• Support the Head of Regulatory Affairs (GRS-I) 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 submission of Marketing Authorization transfer and relevant post approval submissions.
• Support expediting product commercialization by ensuring that country's registration requirements are fulfilled and registration approvals are obtained as quickly as possible.
• Review, analyse, coordinate and provide feedback to HRS (GRS-I) in matters relating to new product submissions and post approval maintenance of products as required.
• Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulatory plans across Pfizer's portfolio.
• Support Labeling and Artwork change management activities for products in responsible portfolio to ensure compliance to information and implementation timelines.
• Review and approve consumer medicine information, packaging labels, promotional material and other documentation as required for regulatory compliance, when required (if applicable).
• Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications e.g. MIMS update.
• Support activities related to product licence 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.
• Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
• Support the maintenance of the relevant record and Pfizer Systems while ensuring timely updates as governed by the SOP.
• Provides oversight and monthly report of activities associated with the approval of a product including such activities as development and coordination of responses to Regulatory Authority inquiries, monitoring and informing with respect to product filings, approvals and launches and track performance against agreed timelines and budget.
• Provide administrative and strategic support for Poison License and Clinical trial maintenance activities (where applicable).

Communication

• Ensure effective communication and collaboration with stakeholders and other function leads (e.g. GCMC, RegOps, PGS, Commercial, Medical etc.).
• Interact and participate in negotiation discussions on regulatory matters concerning Pfizer's portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.
• Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.

Inventory Support

• Support HRS (GRS-I) in coordinating with PGS (and other relevant stakeholders), 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/review of promotional materials that are in keeping with Pfizer's standards by providing the latest labeling information and strategizing product labeling to Pfizer's benefit.
• Provide regulatory input to HRS (GRS-I) to support marketing plans, product launches, and other cross-functional activities.

Regulatory Compliance

• Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.
• Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, and international regulations and Pfizer SOPs.
• Support HRS (GRS-I) to ensure registered products are fully compliant with all relevant legislation and SOP procedures.
• Coordinate with HRS (GRS-I) on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Regulatory Authority.

Skills

• Bachelor's degree in Science or Pharmacy(Pharmacist degree may be mandatory in some countries)
• Experience in Regulatory Operation and submission for NPRA, an advantage if they have done submissions for Southeast Asia countries.
• Understand end-to-end submission for NPRA,
• Fluent in English written and spoken communication skills
• Good knowledge of international or local regulatory guidelines and codes
• Preferably with knowledge across multiple therapeutic areas
• Meticulous nature and proficient in data tracking and consolidation
• Proven ability to consistently deliver to time, cost, and quality standards.
• Ability to effectively deliver in a complex matrix environment.