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, labeling review, among others,
to ensure the company's compliance with 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 proactiveness are highly prized

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

2. Quality Control/ Assurance

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

3. Medical Affairs

a. Assist in coordination for Spontaneous Adverse Drug Event Reporting.
b. Coordinate for Risk Management Plan, PSUR
4. Business Development
a. Coordination for Artworks of New Products (both for CLIDP, Trader or GPPL Products)
b. Coordination of product recall.
c. Coordination on spontaneous ADR.
d. Coordination on quality issues.
5. Legal Affairs
a. Oversee that all TM applications are applied and certificates are maintained.
6. Marketing Team (PMs, SPMs)
a. Review and approve detailers as per the MCP.
b. Provide guidance in allowable claims for promotional materials
7. Sales (Field Force)
a. Provide letters to institutions and individuals to clarify the following for biddings and inclusions (see samples below):

The rationale for some products without BE is based 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

b. Coordinate for product complaints and Adverse Drug Reactions, PV

8. Logistics/ Warehouse
a. Coordination on samples with defects from GBPI warehouse.
b. Coordination on defects, quality, storage and shipment issues on stability.
c. Semi-annual Routine Inspection of the warehouse.
9. Pharmacovigilance
a. Coordination on Adverse Drug Reaction and Product Complaints.
b. Provide training on PV during ITP, e-Learning and to HCPs.
c. 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