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Job Description

Role:

Reporting to the General Manager, Takeda India - The Head of Regulatory Affairs, India will provide leadership and strategic direction for Takeda’s product portfolio by prioritizing the pipeline and overseeing the regulatory strategy for products in development for regulatory approval, as well as regulatory pathways for life cycle management opportunities for new and already approved and marketed products.

Takeda expects to significantly expand its presence in the country and increase its workforce by creating a great opportunity to grow the aspirations of the leader. The company wants to bring in innovative treatments to India to serve unmet patient needs, expand presence in all states and in private sector and bring in Dengue vaccine to India, thus Regulatory Affairs role is critical to accelerate the availability of such solution in the country.

The role exists to lead and manage Regulatory Affairs operations for Takeda India towards ensuring its compliance to local Country Regulators, Health Authority and Takeda ’s Global Quality requirements for importation, licensing, local testing, storage, distribution and local repackaging of products. He/she will provide leadership in implementation of regulatory strategies to obtain and maintain marketing authorizations for drugs/medical devices, vaccines, and communication of general regulatory requirements in support of licensing. The incumbent is also responsible for acting in compliance with country policies and practices to reduce Takeda ’s exposure to regulatory risks as well as for developing the local Regulatory team as appropriate. Travel is required to meet the relevant Distributors & HAs in the concerned countries.

The position can be based out of Mumbai or New Delhi.

Direct Report: Team of 5

Internal Key Stakeholders: Country Leadership Team, Global and Regional Regulatory Leads, Cross-Functions (Franchise Commercial, Medical Affairs, Public Affairs and Government Affairs, Marketing, Legal, Supply Chain, Strategy and Key Account team).

External Key Stakeholders: Regulatory Agencies in India (not limited to CDSCO, SDC, NIB, Port Offices) and Industry Associations.

Role Responsibilities:

• Lead country team for new product registrations, license extensions, variations, renewals according to agreed timeline, and ensure approvals in a timely manner.

• Monitor applicable regulatory requirements; assure compliance with Takeda’s and external standards.

• Respond to DCGI’s requirements which satisfies dossier by strict deadlines.

• Maintain and archive regulatory files in a format consistent with requirements.

• Establish appropriate communication within RA and other functions primarily at project level.

• Develop regulatory project plans, and align with global, regional and local marketing strategies. products/projects (product owner).

• Prepare, review, and approve labelling and SOP’s.

• Review promotional material or SOP’s for compliance with local regulations.

• Maintain databases.

• Respond to requests for information from global/regional RA colleagues.

• Assist with the development of regulatory project plans and strategies.

• Keep up to date with changes to regulations and standards, and ensure relevant colleagues are advised of the implications of such changes.

• Liaise with Franchise and CMC Regulatory Affairs and other colleagues to ensure open and up to date communication of the status of products and projects and relevant regulatory requirements.

• Liaise with the relevant Distributors in Indian Sub-continent as appropriate.

• Develop and implement training of local Regulatory Affairs staff as required.

• Develop & retain Talented Regulatory team members as appropriate.

The successful candidate will be a seasoned regulatory affairs, leader to oversee the development of regulatory strategies at all stages of development to facilitate the earliest possible approvals of the company’s regulatory applications for new products, line extensions and new claims, uses and dosage regiments for existing products together with applicable regulatory promotional practices. He /She will be a strong subject matter expert in regulatory processes, laws and regulations.

Role Requirements:

• 10+ years of proven work experience in Regulatory Affairs in the Pharmaceutical/ Healthcare, or organizations in other regulated sectors
   - Significant experience in the pharmaceutical/ healthcare industry in regulatory drug development and/or product approval/launch.
  

• 5+ years of experience in a managerial or team leadership role as Regulatory Affairs​
  - Must have excellent organization skills and ability to ensure a multitude of tasks are appropriately delegated, managed, and completed. Experience in coordinating a small team. Adept in working in matrix environments.
  

• Program Management Experience
  - Proven leadership and program management experience, it is critical that candidates understand how to leverage and optimize partnerships with other functions within R&D and company-wide, e.g., legal, corporate compliance, business development, commercial and HR.
  

• Specific Technical Skills related to the “Regulatory Affairs” of the Pharmaceutical Industry in India
  - Successful contribution to a major/complex regulatory approval at the country level. Must be well versed in Indian/India Sub continent regulatory requirements, including ICH requirements and regional requirements for assigned territories, and have a good understanding of current global and regional trends in Regulatory Affairs, and ability to assess the impact of these requirements on the business
  

• Significant experience in managing relationships with institutional and non-institutional stakeholders, at national and regional level
  - Track record of successful interactions among regulatory and health authorities at a National/regional level (DCGI, Ministry of Health, Department of Pharmaceuticals, Niti Ayog, NPPA).
  

• Complexity and Problem-Solving skills
  - Must have a proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities and demonstrate a proven track record of excellent influencing and negotiating skills in the concerned countries as much as possible.
  

• Education
  - Should hold a bachelor’s degree in Science or related discipline or equivalent

Critical Leadership Capabilities

• Strategic Thinking
  - Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business.
  - Defines “success” from various perspectives to develop better solutions for our patients and customers.
  - Sees opportunities beyond the scope of own role and influences others to adopt new and effective ways of working.
  - Uses broad understanding of social trends, the healthcare ecosystem, and the pharma business to drive innovative solutions that significantly impact patients and customers.

• Collaborating and Influencing
  - Creates the environment that inspires and enables people to move the organization forward
  - Makes the extra effort to meet with people, understand diverse perspectives and effectively work together.
  - Enables the team to work collaboratively and have challenging discussions.
  - Spends significant time deliberately and consistently engaging individuals and teams from all levels of the organization.

• Driving Results
  - Focuses on the few priorities that matter most and delivers superior results
  - Creates clarity, fostering alignment and accountability.
  - Is courageous in making and implementing decisions based on sound business judgment.
  - Builds structures and processes that reduce unnecessary complexity.

• Innovation - Leading Change
  - Elevates the capabilities of the organization for now and the future
  - Invests time in helping others to enhance their skills and perform at a higher level.
  - Optimize teams by recognizing and leveraging the potential in diverse people.
  - Identifies and develops the next generation of leaders for the global organization, thinking ahead to what will be required for the future.

Other Personal Characteristics

• High ethical Standards- Patient Trust Reputation Business

• Excellent verbal, written, communication skills and demonstration of excellent interpersonal skills are required.

• Clear understanding of business needs, and a proven ability to consistently assess resource requirements and manage staff recruitment.

• Ability to think strategically and critically evaluate risks to regulatory activities.

• Excellent leadership and people management skills, in terms of management of workload and training and development of members of the team are required, as well as directing others in accomplishing objectives.

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