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Regulatory Affairs Manager
- Global MNC
- Working with multiple stakeholders
About Our Client
Our client is a leading pharmaceutical company that is a key brand name in every household. One of the largest producers of pharmaceutical drug products and over the counter products and also a world leader in veterinary pharmaceutical products. With continuous growth of the Southeast Asia economy, they are a business with rapid growth and strong branding over the years in the region. As part of the growth plans and the building of a strong name and reputation, they are looking for a proven Regulatory Affairs Manager to manage future projects and regulatory requirements for the company's presence in Indonesia
This will be an exciting challenge for an individual to be part of a leading brand. Key responsibilities will include but are not limited to:
- The RA Manager is the Country CC Lead and responsible for all regulatory affairs activities of BCC including all maintenance and development product activities, for domestic and export markets, dealing with the relevant Health Authorities in relation to the BCC portfolio to include pharmaceuticals, medical devices, cosmetics and food supplements marketing authorization /permission / notification
She/He will manage the whole processes of achieving new registrations and maintaining existing registrations in line with short term and long term business objectives of BCC and in compliance with all national laws and regulations and company SOPs and policies.
Coordinate and liaise with GRA (Exported Country RA, Regional & Global RA) & Product Supply (Global & Local) to provide relevant documentation needed by importing countries that gets goods from Jakarta such as GMP, CPP and other necessary document.
In coordination with Country Head of RA to support the monitoring of RA CC team performance and to ensure RA activities are completed in agreed timeline by e.g. giving direct feedback for delays and necessary action to bring it back on track.
The RA Manager, as the Country CC lead is essential for the success of the company as this function ensures that our products are registered in a timely manner and existing licenses and market authorizations are maintained.
Success of the position is measured through the achievement of company's strategic goals strategically influence the regulatory environment to ensure success of future projects
The Successful Applicant
We are looking for high calibre talent who have strong working experience in the pharmaceutical industry. In addition, you will have good written and verbal communications in English.
- Life Sciences or equivalent scientific degree with a minimum of 4 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven experience in Consumer Care environment, health authority interactions, managing projects and resources. Proven experience in OTC registration and at least one further Consumer Care category: food, cosmetics, or topical/ingested medical devices
- Ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills
- Convincing presentation skills are required. Demonstrated cross-functional communication skills
- Ability to manage complexity; focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
- Strong managerial and leadership skills to lead and motivate cross functional teams, in line with our company LIFE values. Strong team building abilities.
- Solid and proved knowledge of all compliance aspects related to the regulatory affairs function.
- Detailed understanding of the operating procedures and policies of the national or agency or deep experience with a related national health authority. Overview knowledge of regulations in other AP countries, US, EU etc. helpful
- Ability to develop effective solutions to diverse and complex business problems
- Ability to clearly voice Bayer's and Global Regulatory Affairs needs, high degree of accuracy and reliability.
What's on Offer
- Opportunity to be a part of a leading business
- The chance to step into a lead role with a global MNC