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Head of Regulatory Affairs, India

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Takeda

6d ago

  • Job
    Full-time
    Expert Level
  • Gurgaon

AI generated summary

  • You need 10+ years in Regulatory Affairs, 5+ in leadership, expertise in Indian pharma regulations, program management, and strong negotiation skills. A Science degree is required.
  • You will lead product registrations, ensure compliance, respond to regulatory requests, maintain files, develop project plans, review materials, and train the Regulatory Affairs team.

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

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.

FAQs

What is the primary responsibility of the Head of Regulatory Affairs in India?

The primary responsibility is to provide leadership and strategic direction for Takeda’s product portfolio by overseeing the regulatory strategy for products in development and managing regulatory affairs operations to ensure compliance with local regulators and Takeda's Global Quality requirements.

What qualifications are required for this position?

A bachelor's degree in Science or a related discipline, along with 10+ years of proven work experience in Regulatory Affairs in the Pharmaceutical/Healthcare sector and at least 5 years in a managerial or team leadership role is required.

What skills are critical for success in this role?

Critical skills include strategic thinking, collaboration and influencing abilities, effective leadership and program management qualities, as well as strong problem-solving capabilities in complex regulatory environments.

Is travel required for this position?

Yes, travel is required to meet relevant Distributors and Health Authorities in the concerned countries.

What experience is preferred for candidates applying for this role?

Significant experience in regulatory drug development and/or product approval/launch in the pharmaceutical/healthcare industry, along with a successful track record of interactions with regulatory authorities at national and regional levels, is preferred.

What kind of team will the Head of Regulatory Affairs manage?

The Head of Regulatory Affairs will directly report to the General Manager and manage a team of 5 regulatory affairs professionals.

How important is compliance in this role?

Compliance is critical, as the role involves ensuring adherence to local regulations and Takeda’s global standards to minimize regulatory risks.

Will the incumbent be involved in training and developing team members?

Yes, the role includes developing and implementing training for local Regulatory Affairs staff and retaining talented team members.

What are the expected internal key stakeholders for this position?

Internal key stakeholders include the Country Leadership Team, Global and Regional Regulatory Leads, and various cross-functional teams such as Franchise Commercial, Medical Affairs, and Government Affairs.

What kind of regulatory products will the Head of Regulatory Affairs handle?

The Head of Regulatory Affairs will handle a wide range of products including drugs, medical devices, and vaccines, focusing on regulatory strategies for both new and already approved products.

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Takeda

Better Health, Brighter Future

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.