Associate Regulatory Affairs Director, Middle East and North Africa

The Company

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.

The Opportunity

We currently have an opportunity for an experienced Associate Regulatory Affairs Director, Middle East and North Africa (MENA), to join our Regulatory Affairs team on a full-time basis.

Reporting to the Director of Group & AMENA Regulatory Affairs, the primary purpose of this position is to lead and manage the MENA Regulatory Affairs strategic and operational activities and oversee and maintain regulatory compliance of iNova's products throughout the region. In addition, to facilitate business growth and the delivery of iNova's commercial objectives by developing and optimising regulatory strategies for existing and new business opportunities.

Key Accountabilities Include

1. Manage the MENA Regulatory Operational Activities
2. Lead and oversee the execution of regulatory activities in UAE
3. Oversee and coordinate regulatory activities in other Middle Eastern markets including the GCC and Egypt, and French Western Africa markets in collaboration with applicable 3rd parties
4. Support documentation requirements for the MENA countries
5. Manage the development, implementation and maintenance of regional Regulatory Affairs procedures and processes to ensure organisational health and operational excellence. Ensure SOPs are current and staff are trained
6. Manage integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies
7. Champions adoption and assures alignment of iNova's regulatory information management system with other organizational systems
8. Provide regulatory leadership to iNova's MENA business
9. Provide leadership and direction to the MENA Regulatory team
10. Manage the MENA Regulatory team in alignment with iNova's business objectives and statutory obligations, ensuring compliance and speed to market for new/changed products
11. Lead, mentor and/or guide development of talent within the team, which includes succession and development planning, performance management and recognition
12. Ensure appropriate interface with key functional groups (Group, AMENA, ANZ and Africa Regulatory Affairs, Quality Assurance, Technical Operations, Supply Chain, AMENA Marketing, Region and Country Management, Sales, Innovation and Business Development) to drive company-wide and cross-departmental initiatives, providing quality and timeliness of regulatory input into cross-functional teams
13. Support cross regional regulatory collaboration and harmonisation, and cross fertilisation of knowledge and expertise to achieve iNova's business and compliance objectives
14. Commercial Support to iNova's MENA business
15. Manage the development and optimisation of MENA regulatory strategies for new business opportunities to maximise the likelihood of regulatory success and speed to market
16. Lead and/or support regulatory due diligence for new products as they are identified through innovation and business development activities
17. Represent Regulatory Affairs as a collaborative partner to provide strategic regulatory guidance to Group-wide and AMENA Regional stakeholders
18. Key regulatory support for major commercial expansion projects in the region and support the creation of dossiers to enable product registrations
19. Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidance, to allow specific activities to be undertaken for growth and compliance projects
20. Develop and maintain strong relationships with internal business teams and relevant external parties, and communicate with these parties in a timely and effective manner
21. Participate in or lead internal cross-regional or cross-functional initiatives, as appropriate

About You

To be successful in this role, you will possess a recognised pharmacy, medical or relevant science university degree with a minimum of 8-10 years experience in the pharmaceutical industry, with at least 6 years experience in the MENA region, a minimum of 2 years of people management experience and good pharmacological/ pharmaceutical/ clinical knowledge.

Other Key Requirements For This Role Include

1. Good understanding of relevant regulatory requirements for medicines, devices, complementary medicines, dietary supplements, cosmetics and foods (Desirable)
2. Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in the regions and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of iNova's products
3. Strong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care products
4. Understanding of matrix organisational issue and ability to communicate to multiple stakeholders to facilitate achievement of key strategic objectives
5. Demonstrated strong interpersonal, communication and influencing skills
6. Demonstrated leadership skills; proven decision-maker, hands-on and action-oriented style

Additional Requirements / Working Conditions

1. Occasional business travel may be required
2. Adhere to company values at all times

How To Apply

If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!