Regulatory Affair Manager

Regulatory Affair Manager

Job Summary

The role of a Regulatory Affairs Manager focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives; Maintaining regulatory compliance of products for the following regulatory activities: initial, renewal, variations, marketing materials, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity. As part of operations, active participation in cross-functional teams (Supply Chain, Business Development, Marketing, Training, Medical Affairs & QA) within the company, is a critical part of this role. The provision of regulatory expertise and insight as well as updates on current local regulations and potential changes that will impact the business environment is a fundamental part of the role and as such good communication skills and pro-activeness are highly prized.

Responsibilities

Regulatory

• Provide clear information on Phil. FDA, DOH, ASEANs new regulations.
• Coordination on BE, CDP, etc.
• Set goals and objectives together with HOs plans for submission.
• Coordination on pending submissions with issues and included in backlog.
• Construction of rationale to expedite processing of evaluation and submissions.
• Attend to auditors during inspection/ visit for the renewal of our LTO.
• Secure FDA approvals for new product launches and promotional activities

Quality Control/ Assurance

• Look after and coordinate for Quality issues coming from the trade, marketing, sales & warehouse (GBPI).
• Decide with HO re: quality, storage, transit and stability issues.
• Provide samples to HO of defective products for investigation and disposition.

Medical Affairs

• Assist in coordination for Spontaneous Adverse Drug Event Reporting.
• Coordinate for Risk Management Plan, PSUR

Business Development

• Coordination for Artworks of New Products (both for CLIDP, Trader or GPPL Products)
• Coordination of product recall.
• Coordination on spontaneous ADR.
• Coordination on quality issues.

Legal Affairs

• Oversee that all TM applications are applied and certificates are maintained
• Marketing Team (PMs, SPMs)
• Review and approve detailers as per the MCP.
• Provide guidance in allowable claims for promotional materials

Sales (Field Force)

• Provide letters to institutions and individuals to clarify the following for biddings and inclusions (see samples below):
• Rationale for some products without BE basing on BCS.
• Rationale for Levocin 500mg IV and 750mg IV on significance in formulation.
• Rationale on expiration of assay results.
• Rationale on Lilac and Duphalac formulation as per PNDF.
• Rationale on types of tablet.
• Coordinate for product complaints and Adverse Drug Reactions, PV.

Logistics/ Warehouse

• Coordination on samples with defects from GBPI warehouse.
• Coordination on defects, quality, storage and shipment issues on stability.
• Semi-annual Routine Inspection of the warehouse.

Pharmacovigilance

• Coordination on Adverse Drug Reaction and Product Complaints.
• Provide training on PV during ITP, e-Learning and to HCPs.
• Construct SOPs and implement the same (Product Recall and Quality Complaints)

Qualifications

• With experience in OTC (over the counter)/ food supplement space
• Graduate with degree (Bachelors/Masters) in Pharmacy.
• Registered pharmacist is preferred
• Minimum of 5-years healthcare practice/ relevant experience, and at least 2-years in managing Regulatory Affairs.
• Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.
• Those with experience in organizing scientific events and studies will have an advantage
• Good communication skills, especially as it relates to transparency, collaboration, and the ability to work across communication channels