Consumer Health: Regulatory Affairs Lead Southern Africa

**Consumer Health: Regulatory Affairs Lead Southern Africa**

**Role purpose**:

- Responsible for the management of the local portfolio including new and existing marketing authorizations in SEA for products in all categories (medicinal, cosmetics, medical devices and food supplement).
- Contribution to the local business growth providing guidance and advice to local business and regional/global functions on the regulatory strategy development and processes as well as issues and risks.
- Represents BCH as a competent and reliable partner to the relevant competent authorities, stakeholders and industry associations on all regulatory and its related scientific matters.
- Operating in a highly complex environment that is developing, the incumbent needs to be able to foresee these changes when making probability assessments based on experience and knowledge of the environment.

**Scope**:

- Country: Cluster SEA (South East Africa)

**Key responsibilities and tasks**:

- VACC leader/Business Leader for the regulatory team in South East Africa.
- Coach & develop the Regulatory function of SAE to ensure consumer centricity, innovation and regulatory excellence & governance.
- Member of the local SEA Management Team & the CH METAP Regulatory Leadership Team.
- Provide management support to the sub-regional regulatory and business leadership to business initiatives in view of the complex & changing regulatory environment and the business expansion plans for the sub-region.
- Drive and actively support the implementation of the regulatory strategy tailored to the special needs of the sub-region
- Drive the regulatory processes and activities in alliance with the overall regional strategy of the portfolio in SEA including new and existing marketing authorizations of products in all categories (medicinal, cosmetics, MDs and food supplements).
- Actively supports the organization with product related issues and risk management activities, by providing regulatory advice to internal partners including Medical, Marketing, Quality, Business Development, regional and global Regulatory Affairs and other RMSQC function in order to contribute to development and marketing processes, incl. licensing-in activities
- Review the external regulatory environment and share intelligence with relevant internal parties, understanding and communicating the Key Tasks: impact of the information in relation to the CH business
- Represents Bayer as a competent reliable partner to the local Health Authorities & responsible for an excellent company image and to the company success by building and maintaining professional relationship with the Health Authorities.
- Serves as BCH representative in trade associations in all regulatory matters, and building regulatory networking with national regulators, local subregional industry organizations and key opinion leaders.

**Key Working Relations**:

- Local, Cluster, Regional & Global Regulatory, Medical, and RMSQC/R&D team
- Country Commercial Lead and respective management team
- Local Marketing, Medical, Drug Safety & Quality
- External: health authority & trade associations

**Experience, Skills and Qualifications**
- Education: University degree in pharmacy
- Proven track record in Consumer Health Regulatory Affairs or related positions at least for 7-10 years with extensive experience in leading major projects
- Demonstrated ability to work in a regulatory capacity supporting business objectives while ensuring appropriate governance.
- In-depth understanding of National and Africa regulatory requirements and experience in managing national registration procedures
- Customer focus & commercial awareness. Team spirit and people management skills.
- Ability to communicate effectively and assertively with sound negotiation skills.
- Ability to communicate complex information to all levels.
- Fluent in English.
- Flexibility in frequent travel

**Application Period**:

- 17 December 2024 - 6 January 2025

**Reference Code**:

- 835892

**Division**:

- Consumer Health

**Location**:

- South Africa : Gauteng : Gauteng

**Functional Area**:

- Regulatory Affairs

**Position Grade**:

- VS 1.3

**Employment Type**:

- Regular

**Work Time**:

- Standard

**Contact Us**

**Address**

**Telephone**

**E-Mail**
- 9 Country Estate Drive, Waterfall City, Johannesburg, 2090.
P O Box 143
Isando, 1600, South Africa