Senior Regulatory Affairs Specialist - Infectious Disease Emerging Markets

Job description

JOB DESCRIPTION:

Maintains and advance’s the organization's ongoing relationships with regulatory commissions and authorities. Coordinates and conducts the assessment of internal controls to ensure Pre Market and On Market product compliance as required by regulatory commissions and authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Prepares and sponsors testimony to governmental or regulatory agencies. Regulatory operations activities including trade compliance (listings, document preparation, legalization) and ongoing establishment license maintenance. Ensure advertising and promotional items are compliant to regulatory requirements. Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information. Engages with industry associations to shape future regulations.

Accountability

Operating within practices and procedures covered by precedents or well-defined policies and review of end results. Decision making authority also allows modification of practices and procedures, determine own priorities.  Non-Financial impact. Role is an advisory & diagnostics type of role.

Problem Solving

Thinking environment is somehow constrained by policies / procedures. Generally able to resolve problems using past experience or precedents. Complexity comes in terms of changes in regulatory changes in global or local quality & regulatory standards and requirements.

Know How

Bachelor’s degree with 3 years of experience in RA, product registration, medical diagnostics. Individual contributor role. Primary contact for regulatory governance within the affiliate.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Philippines > Taguig City : Venice Corporate Center

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)