Regulatory Affairs Lead

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Job Description

At Takeda we are guided by our purpose of creating better health for people and a brighter future for the world. Every corporate function plays a role in making sure we as a Takeda team can discover and deliver life-transforming treatments guided by our commitment to patients our people and the planet.

People join Takeda because they share in our purpose. And they stay because were committed to an inclusive safe and empowering work environment that offers exceptional experiences and opportunities for everyone to pursue their own ambitions.

OBJECTIVES/PURPOSE: Lead and develop India regulatory strategies for existing products and pipeline molecules in compliance with applicable Indian rules and regulations. Own local regulatory operations for assigned therapeutic areas to ensure timely new product registrations lifecycle maintenance and regulatory support for clinical trials enabling acceleration of key global assets. Proactively monitor regulatory landscape changes manage regulatory risk and build strong partnerships with Health Authorities and industry associations.

Key accountabilities

Regulatory plan development and strategies

• Develop review and recommend optimal India regulatory strategies and submission timelines for pipeline products in the assigned portfolio.

• Ensure India Regulatory Plans align with Product Team/Area strategies and the LOC business case.

• Coordinate with cross-functional teams (e.g. Quality CMC Medical Clinical Safety Supply Chain and Legal) and global stakeholders to ensure timely availability of required documents for dossier preparation.

• Actively participate in cross-functional LOC teams to provide regulatory guidance and ensure timelines are met or improved.

• Manage clinical trial regulatory activities to enable earliest possible approvals of clinical trial protocols and related submissions supporting global acceleration of priority assets.

• Anticipate regulatory landscape shifts and communicate risks/opportunities to local and global leadership.

• Ensure compliance with country policies and Takeda practices to reduce exposure to regulatory risk.

Regulatory tools

• Maintain timely updates to regulatory databases per LOC regulatory plans.

• Ensure completeness/accuracy of data and achievement or improvement of compliance metrics (e.g. outstanding submissions/approvals).

Submissions and approvals

• Prepare high-quality regulatory dossiers and submit within planned timelines.

• Request and obtain submission-ready regulatory items prepare/format dossiers to local requirements execute submissions and archive appropriately.

• Secure Health Authority approvals to meet launch plans and maintain product licenses.

• Provide high-quality responses to Health Authorities within due dates.

• Complete approval processes communicate approvals internally archive dossiers/approval documents and track post-approval commitments.

• Perform regulatory responsibilities for labeling and packaging development to ensure compliance with local and corporate requirements and business needs.

• Prepare periodic regulatory reports (submissions/approvals) for local management.

• Provide performance metrics aligned with Area and Regulatory Affairs criteria for LOC/Area/Regional leadership.

Regulatory compliance

• Maintain marketed products in compliance with local and corporate requirements including labeling/PI packaging label change management and registered CMC commitments.

• Conduct periodic compliance self-audits to identify issues and implement CAPAs based on findings.

• Develop update and implement SOPs aligned with Global Regulatory Affairs policies (Regulatory Quality Systems) local regulations and Good Regulatory Practices.

Stake holder management:

External

• Establish and sustain relationships with key regulatory officials and through industry associations to foster a positive regulatory environment.

• Monitor India regulatory requirements organizational changes and policy shifts; communicate implications to relevant stakeholders.

• Support development and execution of external regulatory advocacy strategies.

Internal

• Build strong understanding of LOC and regional organization and ways of working.

• Establish credibility as a strategic business partner and be a valued contributor in decisions with regulatory impact.

• Act as primary liaison with regulators on Takedas key RA projects in India.

People leadership & capability building

• Lead coach and develop a team of regulatory executives (where applicable).

• Support the Country Regulatory Head in elevating team capability via structured engagement knowledge-sharing and training.

Experience

• 10 years of experience in Pharmaceutical Medical Device or CRO industry.

• Minimum 2 years of people/team management experience.

Skills & competencies

• Strong knowledge of Indian regulatory requirements for pharmaceutical product registrations and interpretation; familiarity with regulatory corporate policies.

• Understanding of India business decision-making processes impacting regulatory strategy.

• Experience/understanding of biologics and orphan drugs (preferred).

• Strong verbal and written communication.

• Project management; stakeholder management; cross-functional collaboration.

• Customer focus; creative thinking; problem solving.

• Ability to build effective working relationships with Health Authorities / MoH.

• Integrity honesty perseverance fairness; business partner mindset.

• Track record in accelerating product registrations/licenses and managing external stakeholders.

• Strong documentation discipline and expertise in RA System and Tool like Veeva

TRAVEL REQUIREMENTS:

• Domestic an international Business Travel

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelors degree in Pharma/life-science or related field

• Masters degree preferred

• Relationship builder with excellent communication and interpersonal skills.

• Strong organizational analytical presentation and problem-solving skills

• Ability to work in complex market conditions with high integrity & judgement

• Expertise in the RA Tool and Systems like Veeva etc.

• Fluent in English

More about us:

• At Takeda we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

• Certified as a Global Top Employer Takeda offers stimulating careers encourages innovation and strives for excellence in everything we do. We foster an inclusive collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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