Manager - Regulatory Affairs - CIS - Pharma

Role: Manager - Regulatory Affairs, CIS

Location: Kyiv, Ukraine

Reporting to: Director - Regulatory Affairs, Emerging Markets

Key Responsibilities: The incumbent, to start with, will focus on Ukraine and subsequently will take charge of other CIS countries in a phased manner

Strategic Responsibilities:

- Formulate, lead and drive the regulatory strategy for new products (incl. FDCs, Differentiated & Complex) submission & approval.

- Regulatory inputs during product ideation, product development, pharmaceutical studies and clinical studies

- Involvement in product development, regulatory submissions / approval & launch support for In-Licence products

- Maintenance of existing registrations (post approval amendments & re-registrations) . Foreseeing the changes in regulatory environments, alerting the management about upcoming changes & changing the product development, regulatory & manufacturing strategies accordingly.

Operational Responsibilities:

- Ensuring on-time re-registrations and avoiding sales loss

- Facilitating manufacturing facility GMP inspections for in-house, contract and in-license facilities

- Ensuring regulatory conformance and compliance

- Ensuring the labelling compliance

- Liaison with In-License partners, IPM, Packaging Development, SCM, Manufacturing & Quality Assurance for regulatory operations activities and providing all the required support to cross functions teams (CFTs) from regulatory department.

- The person will act as a SPOC for all regulatory related matters.

Operating Network:

Internal: Global Regulatory & Quality Organization, IP, Packaging, SCM, Corporate Legal Team, FTOs, Third Party Manufacturing Plants

External: Regulatory Agencies in Ukraine, In-License partners and External service providers

Nidhi Dhyani
+91.11.43138644