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Job Description

Job Title: Regulatory Affairs Lead, India

Location: India, Gurgaon - Haryana

About the role:

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

• Responsible and accountable for local regulatory operations in the assigned therapeutic areas ensuring timely grant of new products registrations and license maintenance.

• Managing clinical trials from regulatory affairs perspective, ensuring earliest approval of clinical trial protocols to support global acceleration of new key assets

• To proactively anticipate and communicate changes in local regulatory landscape to the local and global 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 Takeda’s key RA projects in the country

• To support the country regulatory head in advancing skills of other team mates and elevate their capabilities through active engagement and other training engagements.

How you will contribute:

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 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).

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

3. Regulatory Compliance

a) 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

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

a) LOC Organisation

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

What you bring to Takeda:

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 with at least 2+ years in managing a team of executives

• 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

• 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 HAs/MoH

• Integrity, honesty, perseverance, fairness

• Business partner mindset

• Acceleration of Product registrations 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

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.

Empowering our people to shine:

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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