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Director – Regulatory Affairs, Gulf

4 weeks ago

Dubai, Dubai, United Arab Emirates Eli Lilly and Company Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The purpose of the Director - Regulatory Affairs, Gulf and META Strategic Business Partner is to:

  • Provide overall affiliate regulatory leadership, vision, strategy, and expertise, for the submission of the new products, maintenance of the marketed products, new business development and other business projects with regulatory impact.
  • Manage all aspects of regulatory affairs for the marketing affiliate. Serve as the link to the GRA Regional Regulatory group and to national regulatory authorities.
  • Manage the Gulf regulatory staff.
  • Lead the strategic direction for new products and new indications across the META Hub in collaboration with other affiliate regulatory directors, specifically to enable earliest submissions/approvals and to create synergies between META affiliates.
  • Serve as regulatory business partner to the META Lead Team.
  • This position covers a broad spectrum of regulatory activities with strategic, commercial and compliance impacts.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Lead the Gulf Regulatory Affairs team by:

  • Developing Affiliate strategic regulatory plan and preparing regular metrics to track affiliate regulatory performance. Putting action plan when needed to improve performance.
  • Sharing updates/alternatives for new products in NPP forums.
  • Ensuring alignment between team and different functions to meet regulatory timelines.
  • Voicing affiliate perspectives and needs to regional, global regulatory and support functions.
  • Supporting Gulf Regulatory team with the local regulatory agency, driving for solutions.
  • Consolidating Gulf regulatory strategies and providing timely response to requests from GRA Regional Regulatory group.
  • Collaborating with GRA Global Labeling, MML Labeling coordinators and drug safety with regards to CDS and reference country labeling compliance.
  • Supporting regulatory team in interpreting existing and proposed legislation with respect to local needs/relevance and in implementing new legislation in a timely fashion.
  • Keeping up to date with the changes in local and global regulatory environment and the impact of regulatory requirements changes to affiliates business opportunities.
  • Communicating local changes to appropriate GRA management and functional experts.
  • Driving and monitoring implementation of the Gulf labeling plan, exploring streamlining and harmonization opportunities, and working with the regional labeling coordinators in developing specific packaging material according to the strategic short term and long-term plans.
  • Ensuring that the team does accurate and complete data entry in corporate regulatory systems e.g., RCubed (Regulatory Reporting Requirements) and RIM (Regulatory Information Management).
  • Facilitating set up of appropriate curriculum for team members and following up on training compliance.
  • Creating department objectives, Budget, and head count plan.
  • Representing affiliate at regional regulatory meetings.
  • Reviewing and approving local procedures.
  • Ensuring team compliance to functional required tools, local SOPs, and local regulations.
  • Ensuring proper focus on registration commitments in Gulf countries with special focus on Marketing Authorization validity, and approved labels for the registered products.
  • Ensuring team maintain a complete archiving system covering the regulatory activities in the Gulf.
  • Aligning with Legal, Regulatory Quality, Regulatory Management on interpretation of unclear legislations to ensure proper understanding and communicate legal decisions to the impacted business partners.

Distribution and Promotion Alliance activities:

  • Ensure the Maintenance of Product Registration Agreement(s) (PRA) between Lilly and Swixx.
  • Ensure strong working relationship is established with Swixx. Ensure proper metrics gathering for the PRA execution by Swixx, escalate and develop gap closure strategies as needed.
  • Ensure the partner receives timely regulatory support from Lilly to enable market continuity.
  • Ensure proper Support to the Partner in regulatory planning and plan execution for new products, new indications, line extensions and ensure internal cross-functional alignment.
  • Intervene to remove barriers as needed to ensure timely provision of support to the partner in line with the agreed timelines for new and maintenance activities.
  • Represent Regulatory Affairs in CIS Alliance Meetings as needed.
  • Manage internal and external stakeholders understanding and expectations in supporting Alliance Partnership.

Contribute to the success of the business by:

  • Establishing and maintaining good relations with decision making staff in the Gulf country regulatory agencies.
  • Supporting the affiliate business planning process, ensuring a coherent planning for all regulatory initiatives and launches alignment with regulatory timelines.
  • Anticipating and resolving complex regulatory problems in the Gulf countries to minimize impact on business.
  • Providing technical support to the affiliate in pricing/reimbursement (as needed).
  • Ensuring proper oversight over Gulf TPOs providing registration services in line with signed registration service agreements and Regulatory quality required tools.
  • Supporting Middle East Area industry working groups through the Gulf regulatory team.
  • Leading regulatory forums across the META hub to develop regulatory strategies for new product/new indication submissions and seek synergies in line with META business objectives.
  • Leveraging interactions with Business, PRA, CA, CS, Medical and Marketing at the Gulf and META level to facilitate cross-functional activities.

People Management – Gulf regulatory team:

  • Create and maintain a positive and effective working environment.
  • Motivate, empower, and challenge people, be reliable team leader.
  • Retain and develop the career plans for subordinates.
  • Conduct regular 1:1 with subordinates regarding activities progress, coaching and achievement of objectives agreed upon.
  • Conduct effective performance appraisal and address performance issues.
  • Ensure team compliance to GPP, red book, privacy etc.

Lead META regulatory strategy by:

  • Influencing and aligning on the strategic direction for major regulatory submissions and external environment shaping, in collaboration with the Regulatory Directors of the other hub affiliates, to identify opportunities for the fastest and most beneficial pathways for new products and/or indication submissions across the META Hub.
  • Participating regularly in the META lead team meetings to share regulatory strategy, actions, status, and perspectives.
  • Providing training and education across functions on regulatory matters and providing regulatory input to strategic plans.
  • As part of the Lead Team, responsibilities go beyond the scope of the regulatory function, to contribute to the overall Hub strategy, internal and external key initiatives aiming for the success of the company's brand equity externally and employees' engagement internally.

Minimum Qualification Requirements:

  • Relevant scientific degree or bachelor's degree in pharmacy or life science.
  • Deep knowledge and understanding of the local and applicable regional and global regulatory procedures.
  • Good knowledge of Gulf regulatory environment.
  • At least 10 years of pharmaceutical industry experience, within regulatory affairs; with experience in dealing with external regulatory agencies, pharmaceutical industry associations, the healthcare systems and marketing needs.
  • Strong analytical, problem solving & negotiation skills.
  • Good knowledge of written and spoken English & Arabic languages.
  • First class communication skills, excellent planning, and priority setting.
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