About the job 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