Vice President - Regulatory Affairs - Healthcare/Pharma

Manage the business relationships with alliance partners, primarily in India and South Africa, and ensure the smooth flow of business operations in these markets.

Implement and enforce licensing agreements with commercial partners, primarily in India and South Africa, however other markets may be considered in the future.

Act as the interlocutor and ensure that it remains well informed of regulatory and commercial progress in the markets.

Work with medical affairs department to coordinate and monitor implementation studies involving the product(s) in the markets.

Interact with local government health officials, stakeholders, key opinion leaders, clinicians, or customers, as required. Responsible for representing the organization at events, meetings or activities within the region and provide presentations or prepared remarks on the product(s) or the company, as required.

Communicate with the commercial partners to ensure regulatory issues are properly addressed and information is provided in a timely manner to support the successful regulatory approval of the product in the territory.

Following receipt of the marketing authorization, work with alliance partners to develop comprehensive sales and marketing plans to adequately promote the product following regulatory approval and ensure these plans conform to the overall goals and objectives.

Establish close working collaboration with commercial partners allowing for smooth business operations and transactions.

Monitor for compliance and due diligence and raise any potential questions.

Ensure commercial partners are providing deliverable on time, in accord with the licensing agreements, and other key provisions of agreement are honored and en-forced.

Require:

Minimum 10 years - 25 years of experience in the healthcare or pharmaceutical sector with appropriate skill and experience relative to the duties listed above. This includes experience working with international companies based outside of India and global commercial products.

Secondary degree in business, business administration, sales, marketing, finance or related.

Fluent command of the English language, both oral and written.

Ability to work well independently, across multiple time zones and geographic areas.

Ability to travel regionally and internationally up to 30%.

Results-oriented, team player dedicated to tackling complex business problems and delivering innovative solutions.