Country Regulatory Affairs Associate Jobs, Medical Jobs, Sheer Logic Jobs
Sheer Logic Management Consultants is seeking to engage a dynamic individual for Country Regulatory Affairs Associate – Tanzania position for one of our clients.
This position has responsibility for Regulatory Affairs in defined portfolios or activity streams or countries. The role may also have responsibility for leading a team of regulatory professionals within their country. This includes:
- Ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans
- Ensure products are maintained and meet internal and external compliance requirements
- Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, area regulatory team, marketing/sales within local commercial business, supply chain and quality etc. Lead a team of regulatory professionals if required.
- Ensure products within scope (inc medicines, devices, cosmetics and foods) are maintained with optimal yet compliant claims, advertising and promotion in line with commercial plans and relevant technical updates in collaboration with Area marketing and relevant teams.
- Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of CH with local regulators, trade associations and other key external regulatory bodies.
- Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.
- Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
- Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs
- Actively contribute to high performing teams, including looking for ways to improve performance. May lead direct reports or cross-functional teams within local market
- Build relationships with key stakeholders and represent in a responsible manner according to company values, in order to communicate CH policies and strategies and negotiate outcomes
- Manage compliance within defined portfolio/activity streams in line with CH expections – support key processes and ways of working (eg, in relation to CMC, quality, product labeling requirements as well as local MoH regulations). Propose solutions to identified issues and implement
- Collaborative working together with other functions ( eg, marketing, supply chain) to deliver agreed NPD and value engineering projects
- Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
- Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business
- Maintain required regulatory compliance databases, systems and processes. Train other compnay stakeholders as required to build knowledge and compliant utilisation
- Maintain high level of knowledge on the science of products within defined portfolio
- BA or BSc Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- Regulatory professional at this level must be skilled in scientific interpretation/evaluation/communication of technical information
- Bachelors or Diploma Regulatory Affairs, Pharmacy
- Position requires practically-applied demonstration of intellect and an ability to interface effectively with internal and external stakeholders (other commercial and technical staff, local senior management, external regulators, trade associations)
- Ideally a minimum of 3-5 years’ experience in Regulatory Affairs,
- Regulatory clearance is a pre-requisite of any product marketing. Compliance to regulatory requirements and management of health authorities is essential to Corporate compliance and product portfolio/sales maintenance. Ability to effectively communicate and negotiate in relation to technical information and regulations is key.
How To Apply
If you believe your career objectives match this exciting position, please forward your application and detailed C.V stating your current position, remuneration, contact details by 1 7 th July 2019 to the Sheer Logic Management Consultants E- Mail email@example.com clearly marking – “ Country Regulatory Affairs Associate – Tanzania ”.
Only short-listed candidates will be contacted. Our Client is an Equal opportunity employer