Reporting directly to the General Manager, Eastern Southern Africa and a dotted reporting line to Medical Affairs Director Africa, the Head of Medical and Regulatory Affairs will also be responsible for ensuring timely registration, pricing and repatriation. He/She will be a leading partner within the full chain of value creation, understanding the current healthcare environment and anticipating how relevant market dynamics may impact how medicines are used. The role holder will be responsible for providing strategic advice in support of business initiatives, maintaining good relations and lobbying with Health Authorities.
We seek to improve public health by finding healthcare solutions for identified patients and through the appropriate and effective use of our products and services, utilizing the highest ethical and compliance standards.
Key responsibilities for the role will include but not be limited to:
Managing the medical aspects of a product(s) or therapy(s) life-cycle within the assigned geographic area.
Evaluating geography specific strategy needs for successful launch and implementation of product(s) or therapeutic areas to support and increase market share.
Driving non-registration or local registration clinical studies driven by his/her team performed with product(s) or therapeutic area(s) within his/her scope of responsibility.
Providing medical/scientific support for clinical development, key opinion leader’s management, market access and commercial activities.
Identifying synergies and proposing appropriate resource allocation for critical medical initiatives.
Enhancing patient-centric approach integration in each product/device/service life cycle management.
Ensuring scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups within the geographic area.
Assuming an active role in the hiring/recruitment and talent management review process for appropriate medical positions, with an emphasis on skill development and improvement.
Understanding the competitive market dynamics and proposing appropriate strategic actions to meet company objectives.
Ensuring that interactions and communications between pharmacovigilance and regulatory have been raised to Senior Management to ensure they are transparent to health authorities.
Establishing the highest ethical standard for the Medical function by demonstrating proactive and effective issue resolution at the Country level.
Working transversally with the strategic units on all activities in order to meet company objectives.
Providing strategic direction based on insights, knowledge and industry experience.
Structuring the department in the most efficient manner to meet business needs.
Managing the medical budget management and proactively monitoring compliance & quality management.
Overseeing continuous performance improvement across all our processes, systems & activities.
Appropriately balancing priorities & activities within a dual reporting relationship.
Providing support for Consumer Heath Care (CHC) and generic activities.
Providing scientific communication to all key stakeholders in the country.
Scientific, professional & ethics based risk management.
External stakeholder engagement & relationships.
Managing and enforcing regulatory compliance.
Desired Skills and Experience
The Ideal Candidate will have the following experience and background:
Medical Doctor qualification; PhD and publications will be an added advantage
Minimum of 7 to 10 years of related experience in the Pharma industry and at least 1-2 years as a Medical Representative is desirable
Strong track record in developing and executing medical strategy for key markets
Demonstrable track record of building and maintaining a key opinion leader’s network within a country
Experience working across functions and building effective partnerships between business units within Medical and Regulatory fields
Experience working within an international company with a complex organizational environment and the ability to operate in a matrix, team oriented structure
Significant leadership experience and proven ability to influence stakeholders
Strong commercial acumen and strategic ability
Experience in reorganization and restructuring
Extensive experience in dealing with safety issues
Strong understanding of the pharmaceutical business
Ability to converse in Portuguese will be an added advantage
The Ideal Candidate will be a leader who demonstrates the following personal traits:
Excellent oral / written communication and presentation skills in country and corporate languages
Drive, energy and results oriented with a commitment to deliver above expectations
Dedicated and persuasive with a “can-do” attitude
High standards of integrity and ability to think outside the box
Self-motivated with a highly entrepreneurial spirit
Strong interpersonal and influencing skills
HEAD MEDICAL AND REGULATORY AFFAIRS