Senior Area Regulatory Director - ME & A
Description: Senior Area Regulatory Director, - Middle East and Africa
- This role is the key account manager for all regulatory affairs matters with the relevant Area Business Team, Market Company Presidents and Market Ccompany (MC) Regulatory Heads and the Global Functions.
- Works with Area Commercial, Market Company Presidents, MC Regulatory Heads and Global Functions to define and deliver the regulatory workplan for the Area, including business growth initiatives, with appropriate resourcing
- Is the major link into the global regulatory organisations (Therapeutic Area, Chief Medical Office) from their Area to ensure priorities are clear, resourcing is provided, issues are addressed and intelligence/best practice is shared
- Is the major regulatory interface for their Area with Global Functions to facilitate communications, inform/educate on market needs, and to resolve issues including changes needed in global policies/procedures
- Reviews,signs off and provides strategic input into complex product strategies for their respective areas,and regional growth initiatives involving regulatory. Supports definition and agreement of the regulatory intelligence, including procedural or dossier content-driven, for their region to optimally support the Regional business objectives.
- Provides the regulatory input into issue management resolution for their Area
- Works with Regulatory Process and Partnership Group to ensure that global SOPs take account of MC viewpoint and that MC regulatory groups know the required standards for Good Regulatory Practice. Supports the MCs to achieve the required standard. This role is also responsible for highlighting to Area and Regulatory Leadership any concerns in an MC meeting the required Compliance standards, including where this is due to competency or capacity issues.
- Supports recruitment, training and development of regulatory in market, where needed. Also, facilitates collaboration between MC regulatory staff (Area meetings) to share best practice, etc.
- Coaches and leads definition of innovative strategies to partner with the relevant regulatory authorities to optimize the predictability of the regulatory outcome and to provide the regulatory platform for optimising and maintaining market access in the allocated Markets.
- Partners and collaborates effectively with key internal stakeholders - within global regulatory (TA, CMO), Commercial, Marketing Companies, Area Medical and Commercial, and external customers – Regional regulators, Health Authorities, Trade Associations etc. Sets high standards and objectives according to AZ values and procedures.
- Ensures the global regulatory organization (TA, CMO) provides an excellent service to customers in Marketing Companies and Areas by enabling rapid and effective submissions and approvals; and seeking to enhance relationships and profile with local Regulatory Authorities.
- Leads regulatory policy, in collaboration with MCRA, for their respective area and leads the management of specified critical agency interactions in the Region (eg, issue resolution or general policy-sharing) ensuring the strategic, longer term, global perspectives are taken into consideration.
- Ensures best practice is shared within global regulatory (TA, CMO) as a whole.
- Coaches and mentors MCRA, EMRADs, RPM Market Desk and other global regulatory staff as appropriate.
- Leader and role model within Global Regulatory Excellence, capable of leading significant projects for the function or cross functional business improvement activities.
- Serves as representative of the international markets for internal and external issues, initiatives, governance teams and process improvements
- Creates, develops and optimises relationships with regulatory agencies, trade associations, and internal groups
- Contributes to the development of global policies and programmes to support and develop the business and ensure effective implementation in own area.
- Monitors changes in the regulatory environment to support and advise the Regional businesses, global teams, functions and global regulatory (TA, CMO) with respect to AZ strategic positions.
- Ensures self or others actively represent AZ outside the company (relevant DIA meetings, trade association meetings, etc) to engage and shape policy on key issues in key markets to facilitate efficient and effective drug development in the designated Markets.
- Significant regulatory experience
- Strong leadership skills
- Strategic thinking
- Communication skills
- Interpersonal/Collaboration skills
- Team-building skills
- Creative thinking skills
- Resource/Budget management
- Availability during MEA area working hours
Essential :Bachelor Degree
Preferred :Degree/ PhD in scientific discipline or equivalent
- Significant relevant experience of regulatory drug development, manufacture, commercialisation or equivalent.
- Proven successful leadership and project management experience
- Successful contribution to a major regulatory approval either at a regional or global level.
- Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
- Good strategic vision and have the ability to command respect at all levels and cultural interfaces. This will be supported by a thorough understanding of the AZ business and commercial processes and regulatory knowledge.
- Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance
- Knowledge and significant experience of International market procedures and legislation
- Knowledge of scientific foundation, sufficient to understand all aspects of regulatory issues in an authoritative way and discuss with technical experts
- Deep understanding of the International Regulatory Environment, global regulatory science and overall drug/biologic development processes
- Direct experience of implementing innovative regulatory strategies for high profile, complex or novel development programs
Internal and External Contacts/Customers
- TAs, Operations and Commercial functions
- Marketing Company Presidents
- Commercial Area Management
- Health Authorities
- Trade Associations
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.