OBJECTIVES/PURPOSE

• To lead and develop Regulatory strategies for existing and future Clinical Trials of Cliantha Research in accordance with the applicable rules and regulations.
• Responsible and accountable for local regulatory operations in the assigned areas ensuring timely grant of approvals and life cycle management.
• Managing clinical trials from regulatory affairs perspective, ensuring earliest approval of clinical trial protocols to support global acceleration of new key assets of our sponsors
• To proactively anticipate and communicate changes in local regulatory landscape to the Cliantha Research leadership.
• To act in compliance with country policies and practices to reduce company’s exposure to Regulatory risks.
• To build partnership with officials in Health Authorities and industry associations to be able to proactively participate in policy shaping and advocacy.
• To act as primary liaison with reg authorities on Cliantha Research’s key RA projects in the country
• To support the country head in advancing skills of other team mates and elevate their capabilities through active engagement and other training engagements.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

SKILLS And COMPETENCIES

• Bachelor’s in Pharmacy, Chemistry, Sciences, Biotechnology, Microbiology, or equivalent degree, master’s degree in relevant subjects will be plus
• Candidate should ideally have 10+ years of experience in Pharmaceutical, Medical Device, CRO industry
• In-depth knowledge of local regulations pertaining to clinical trial requirements for pharmaceutical products and understand its interpretation as well as Regulatory Corporate Policies
• Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy
• Understanding of relevant local regulations in handling Biological & orphan drugs (preferred)
• Excellent verbal & written communication skills
• Project management
• Stakeholder management
• Customer Focus
• Creative thinking and problem solving
• Able to develop effective working relationships with MoH
• Business partner mindset
• Acceleration of approvals and licenses
• External stakeholder relationships & management
• Documentation
• Cross-functional collaboration

Critical leadership capabilities

• Problem solving
• Managing complexity
• Learning agilities
• Self-awareness
• Collaboration
• Drive for results

Responsibilities

1. Regulatory Planning

a) Regulatory Plan Development

Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for assigned portfolio based on regulatory expertise with country regulations & MOH processes.

Manage and ensure the country Regulatory Plans are in alignment with Product Teams and the country’s business plan.

b) Process Management

i) Coordinates the process with other functional members, sites and corporate (Legal, Administration, etc.) to ensure timely availability of required documents for dossier preparation.

ii) Active participation in cross-functional teams within the local operating company (LOC) and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.

c) Regulatory Tools

i) Timely update of all databases as per LOC regulatory plan

ii) Ensure data is complete and accurate and that the updates meet /or improve upon the established compliance metrics (i.e. outstanding submissions/approvals)

2. Submissions and Approvals

a) Dossier Preparation

Prepare a quality regulatory dossier and submit within the planned timelines.

Activities include:

• Request and obtain the various regulatory items needed for the local submission
• Prepare/format the dossier to ensure it meets local requirements
• Implement the submission and archive appropriately

b) Gain Regulatory Approval

Gain Health Authority approvals to meet product launch plans and ensure product maintenance.

Activities include:

• Provide quality responses to the Health Authorities by due date
• Complete regulatory approval process and gain product licenses
• Communicate Product approval
• Archive submission dossier and approval documents
• Track post approval commitment, if any
• Perform regulatory responsibilities related packaging development
• Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs

c) Metrics Review

i) Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management.

ii) Provide regulatory metrics on performance that are aligned with Regulatory Affairs criteria to measure regulatory performance

3. Regulatory Compliance

a) Compliance Maintenance

i) Take appropriate actions to maintain all products/trials in compliance with local and corporate regulatory requirements [eg. all aspects of labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the DRA

ii) Conduct periodic compliance self-audit to identify potential compliance issues

iii) Take corrective actions plans based on regulatory audit findings

b) Good Regulatory Practices (GRP)

Develop, update and implement appropriate SOPs as required by the Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.

4. Regulatory Influence

External

a) Regulatory Customer Relations

Establish relationship with key regulatory officials (throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research.

b) Regulatory Environment Changes

Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.

c) Influence Strategy

Supports the development and implementation of the established external regulatory influence strategy.

Internal

i) Learn and understand the local and regional organization and functions.

ii) Build functional partnership and credibility to maximize regulatory value in support of business decisions.

iii) Recognized as a valued member of decision making process that has or potentially has regulatory involvement