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Location:
Yelahanka, Karnataka, India
Job reference: R-019732
Posted date: Dec. 28, 2017

The Associate Director – Product Regulatory Affairs is accountable for the development and implementation of the regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver a rapid approval for regulatory maintenance activities in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.  The Associate Director – Product Regulatory Affairs possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic maintenance processes and strategies.  Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or global product teams and relevant stakeholders.

Accountabilities/Responsibilities:

  • Accountable for the development and implementation, at a regional or global level, of innovative regulatory strategies and for ensuring that the strategy is designed to deliver a rapid approval of regulatory maintenance activities.
  • Leads the Global Regulatory Strategy Team (GRST) with key contributing members from a regional perspective, Manufacturing (Operations) and Regulatory Project Managers, to ensure prioritized objectives are delivered to time and quality. Through the GRST, ensures that regional regulatory needs for post-approval changes and post-approval commitments are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Plan.
  • Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional and/or Global Product Teams.
  • Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures for post-approval changes and post-approval commitments.
  • Accountable for CDS/SmPC/USPI updates, and approval of regulatory impositions to market product information.  
  • Accountable for product maintenance, supply and compliance activities associated with marketed brands.
  • Lead regulatory defense interactions and provide regulatory leadership to issue management teams.
  • Lead ad-hoc regulatory interactions, ensuring effective regulatory representation in partnership with appropriate technical experts at all health authority meetings.
  • Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise regional and/or Global Product Teams (GPT) accordingly.
  • Provide regulatory leadership as needed in product divestment and product withdrawal.
  • Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.

Minimum Requirements –Education and Experience

  • University Degree in Science or related discipline
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
  • >13 years relevant regulatory experience, including license maintenance and labelling, and of working across a range of markets, including regulated markets
  • Thorough knowledge of the regulatory product maintenance process
  • Leadership skills, including proven leadership of cross-functional project teams experience
  • Excellent English written and verbal communication skills
  • Thorough scientific knowledge sufficient to understand all aspects of regulatory issues
  • Proven ability to think strategically and critically evaluate risks to regulatory activities.
  • Proven ability to work strategically within a complex, business driven, regulated environment.
  • Experience of working with people from locations outside of India, especially Europe and/or USA

Preferred Experience

  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions

Skills and Capabilities

  • Strategic thinking
  • Innovation
  • Initiative
  • Leadership
  • Supplier and Partner management
  • Project management
  • Strategic Influencing
  • Problem solving
  • Independence
  • Team working
  • Customer focused
  • Understanding of the importance of Continuous Improvement
  • Knowledge sharing

Internal and External Contacts/Customers

  • Internal science functions
  • Manufacturing organisation
  • Marketing Companies/Local Affiliates
  • Patient Safety organisation
  • Health Authorities

Reporting Relationship

  • Direct Reports - None
  • Indirect Reports -None
Global Regulatory Lead - Associate Director
Regulatory

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