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Job Description

OBJECTIVES/PURPOSE

• To lead and develop Regulatory strategies for New Products, existing products and other pipeline molecules of Takeda in accordance with the applicable rules and regulations.

• Responsible and accountable for local regulatory activities (driven by local or corporate initiatives) and peformances in registering new products and new indications.

• The individual will execute all the regulatory activities related to Global Clinical Trials, registration requirements, Renewals and products lifecycle maintenance for India and neighboring countries ( Sri Lanka, Bangladesh & Nepal) as per Business needs.

• To act in compliance with country policies and practices to reduce company’s exposure to Regulatory risks.

• Lead, Development and Implementation of Regulatory Policy & Advocacy Strategy.

• Develop the policy content / material, Identify, develop and produce policy material

• To build partnership with various regulatory agencies in India and to keep updated on changes to local and global regulatory environment/trends and impact of the regulatory requirements changes to the local business opportunities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s in Pharmacy or Masters in Chemistry, Sciences, Biotechnology ,Biomedical Engineering,  Microbiology, or equivalent degree.

• Candidate should ideally have 08 -10 years of experience in Pharmaceutical, Medical Device, CRO industry.

• In-depth knowledge of local regulations pertaining to product registration 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.

• Strong knowledge of relevant local regulations in handling Biological & orphan drugs

• Excellent verbal & written communication skills

• Project management

• Stakeholder management

• Customer Focus

• Creative thinking and problem solving

• Able to develop effective working relationships with HAs/MoH

• Integrity, honesty, perseverance, fairness

• Business partner mindset

• Acceleration of Product registrations and licenses

• External stakeholder relationships & management

• Documentation

• Cross-functional collaboration

Responsibilities

1. Regulatory Planning

Regulatory Plan Development

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

Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country’s business plan (3/1).

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.

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

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

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

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 Area & GEM Regulatory Affairs criteria to measure regulatory performance to LOC, Area & Regional management.

3. Regulatory Compliance

Compliance Maintenance

i) Take appropriate actions to maintain all local marketed products 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

Good Regulatory Practices (GRP)

i) 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

 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.

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.

Influence Strategy

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

Internal

LOC Organization

i) Learn and understand the local 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

Locations

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