Home Head/VP/CEO/President/GM Director - Regulatory Affairs | AstraZeneca | Bengaluru, India

Director – Regulatory Affairs | AstraZeneca | Bengaluru, India


AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.

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You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.

Position: Director – Regulatory Affairs

Location: Bangalore, Karnataka, India

Job Description:

You are responsible to direct regulatory strategies to gain rapid and high-quality approvals, ensuring high standards of regulatory compliance, in order to achieve the company’s business objectives. This role would report to the Vice President – Medical & Regulatory Affairs.

Key Accountabilities/Responsibilities:

Direct regulatory strategies to achieve rapid and high-quality approval and facilitate the rapid launch

  • Maintain knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy

  • Provide inputs on product strategies from an early stage of product development

  • Align regulatory priorities to business strategies

  • Direct submission strategies in a joint agreement with identified stakeholders and optimize the balance between risk and commercial benefits

  • Make sure local regulatory strategies consistent with global product strategies and local priorities

  • Ensure regulatory plans are developed in conjunction with key stakeholders and ensure the allocation of adequate resources and deliver plans on time

  • Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch

  • Handle Regulatory oversight for Frontier market as assigned by Area Regulatory Director

Maintain product licenses to a high standard

  • Monitor status of all product licenses

  • Project manage changes in product licenses and coordinate with other changes, planned and in progress

  • Maintain complete documentation records

  • Communicate changes to licenses status promptly

  • Allocate adequate resources to license maintenance

Build and retain effective regulatory team, maintain cross-functional communication

  • Recruit, retain and motivate a regulatory team

  • Agree on team members’ roles, responsibilities, performance criteria, objectives, and standards of work execution.

  • Communicate as required and ensure effective downward and upward communication channels are in place

  • Direct, coach, guide, support, reward, and develop the team.

  • Monitor subordinates’ performance and identify areas requiring development, including poor performers, taking action as appropriate

  • Conduct talent review; develop career and succession plans.

  • Identify a development plan for each regulatory member

  • Act as GXP lead / develop GXP lead within the team and drive compliance mindset &  ensure compliance across GXP areas within the Organization.

  • Facilitate and solve conflicts within the team and cross-functionally.

  • Collate best practice examples & learning; share with the team and regional/global colleagues

Provide Leadership and direction to team

  • Create and communicate a clear vision for the department.

  • Define long-term objectives and short-term challenges.

  • Strive to ensure performance and achievements.

  • Take decisions and accountability for actions.

  • Build commitment within the team.

  • Enhance positive attitudes and mindset. Demonstrate confidence and conviction.

  • Stimulate conceptual thinking and Creativity; Challenge the status quo for continuous improvement.

  • Influence and input in company decision.

  • Create an open and trusting atmosphere

Shape and influence the regulatory environment to achieve rapid and high-quality approval

  • Work with other regulatory teams and other functions to ensure the identification of key stakeholders.

  • Ensure a cross-functional action plan is in place with each identified stakeholder.

  • Communicate regularly with all stakeholders.

  • Ensure the involvement of each stakeholder and ad-hoc support to maintain/enhance relationships.

  • Develop excellent relationships and partnerships with Regulatory Authorities

  • Contribute to the New Drug Committee responsible for portfolio planning to facilitate effective and timely decision making on new product/line extensions by a country leadership team

Adherence to AZ and industry code of conduct, ethics, and good regulatory practices

  • Align with the values and vision of AZ

  • Actively encourage the development of the AZ culture

  • Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance, and Audit requirement

  • Ensure compliance from all staff to guidelines, codes, policies, and procedures

  • Ensure that company confidentiality is maintained (i.e. intellectual property, product information, strategic and salary information)

  • Disclose potential breach of codes or conducts

  • Direct involvement in the training of Regulatory issues to other functions

  • Oversee the Patient safety (Pharmacovigilance) function to ensure compliance to regulations and company procedures.

Issue Management

  • Provide detailed information of the regulatory status of affected products, and advise on the appropriate regulatory process

  • Liaise with regulatory authorities to agree on an ethically, acceptable outcome

  • Monitor and complete agreed action

  • Work with cross-functional teams and external agencies to formulate responses to issues

Monitor local and global regulatory environment for significant changes and communicate to key stakeholders

  • Monitor, understand and communicate changes in the local, regional and global regulatory environment

  • Monitor the impact of regulatory changes on AZ products and its local implication and take appropriate actions to manage risk

  • Study and interpret global and local business environment e.g. social and political as appropriate

Key  Functional Capabilities

  • Excellent Scientific and regulatory knowledge

  • Excellent Communication Skills

  • Good Planning and Organizational Skills

  • Ability to develop Strategic Partnerships

  • Demonstrate AZ Values Consistently

Desired Candidate Profile:

  • The rich and diverse experience of New drug Approval/GCT/ pharmacovigilance/IL &RC/biologics

  • Business and technical expertise including the latest regulatory developments

  • At least 5 years of experience with innovator/R&D driven pharmaceutical MNC

  • 3+ years of  Team management experience will be preferred

Qualification: Bachelor Degree in Medicine OR Master degree in the field of Science/Pharmacy/Medicine OR Doctor of Philosophy

Experience: 15+ years of Bio-Pharmaceutical experience (including Regulatory Affairs), of which minimum 3 years middle-senior management experience

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