Regulatory Associate Manager, Pharmaceutical Solutions - Shanghai, 中国 - International Flavors & Fragrances

描述

Job Description

The Associate Regulatory Manager is responsible for providing expertise for the development and maintenance of our Pharmaceutical Solutions products within the region. This role includes regulatory leadership focusing on the Pharmaceutical Solutions products and involvement in product registrations and direct agency interaction within the region, and as applicable, with other agencies. This role will provide regulatory support to regional customers directly and can be actively engaged in regional industry associations (e.g. IPEC)

How you will contribute:

• Support to existing product portfolio in their pharmaceutical applications, providing expertise and insight and supporting lifecycle management of products, including opening new market/applications and introduction of existing products into additional countries/jurisdictions within the region.

• Active involvement with new projects and new product developments, defining regulatory strategies and supporting dossier work on an as needed basis.

• Help ensure that relevant risk evaluation and management processes are followed and completed.

• Help identify advocacy needs in the region and work with colleagues globally, including the Scientific and Public Affairs team to pro-actively track and assess impact of relevant regulations and guidance documents with reference to IFF's API's and excipients products.

• Interface with local competent authorities and trade associations (e.g., IPEC), to understand regulatory issues of direct impact to the use of IFFs Pharmaceutical Solutions products that are used in finished drug products and assist with their implementation.

• Translator of global and regional regulatory issues to the different internal stakeholders (e.g. commercial teams, quality, operations, ...) as well as external stakeholders (e.g., customers).

• Interface with internal business functions to define optimal regulatory pathways aligned with business plans, development opportunities and R&D objectives.

• Provide regulatory support for customer regulatory filings as needed.

• Develop, submit and support regional dossiers for approval of excipients.

• Provide regional regulatory input during cross functional business projects.
EXTERNAL FOCUS:

• Expected to spend some time travelling (max 20%) to support business-customer interactions, trade associations or interacting with government officials.

Job Requirements

What you will need to be successful:

• Expert and hands-on knowledge on the global and regional regulatory landscape for pharma excipients and their use in finished drug products

• Extensive regional experience in interaction with regulatory agencies and track record in product clearance/registrations and regulatory advocacy

• Expertise in EU and US pharmaceutical regulations and excipients is an advantage

• Preferably MSc degree in Pharmaceutical Science, Regulatory Science, Biology, Toxicology, or Chemistry or similar fields

• + 5 years Regulatory Affairs work experience in the Pharmaceutical Industry with excipients

• Demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills across a global team

• Strong interpersonal skills

• Very good organization, and project management competencies

• Strong influencer and collaborator with interdisciplinary teams

IFF is an Equal Opportunity Employer.
At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex or veteran status. We strive for inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.