Experience: 6 to 11 yrs.
Key Responsibilities
Strategic
Formulate, lead and drive the regulatory strategy for new product submission & approval. Provide regulatory inputs during product ideation, product development, pharmaceutical studies, preclinical & clinical studies.
Active involvement in product development, regulatory submissions/approval & launch support for in-licensed products
Maintenance of existing registrations (post approval amendments & re-registrations) and handling of quality complaints
Foreseeing changes in regulatory environment, alerting the management about upcoming changes & aligning the product development, regulatory & manufacturing strategies accordingly.
Operational
Proactively coordinate & provide support to the country regulatory w.r.t. documents, answering deficiencies and arranging samples. Provide support for manufacturing facility audits, art-work approval process, trade dress approval process and pharmacovigilance.
Support & coordinate with SCM for product launches. Facilitate local manufacturing/re-packaging activities and IP coordination i.e., patents & trademarks.
Operating Network
Internal: Regulatory Affairs team, Biologics, In-Licence Partners, R&D, AR&D, IPM, Packaging Development, Manufacturing, Quality, SCM and Business Development
External: In-Licensing Partners, Regulatory Consultants
Technical Requirements: In depth understanding of pharmaceutical science and regulatory affairs. Knowledge of product development, analytical development, manufacturing & quality, Intellectual Property Rights (Patents & Trademarks), preclinical, Bio-equivalence & clinical studies.
Educational Qualifications: Post Graduation in pharmaceuticals is necessary.
Experience Required: Minimum of 7 years experience in pharmaceutical industry of which at least 4 years in a role handling regulatory affairs, preferably in Russia/CIS markets.
Key Personal Attributes
Demonstrates cross cultural sensitivity
Highly self driven with good relationship & influencing skills
Displays good leadership capability
Aptitude for and interest in learning new languages
Relocation Assistance to Moscow, Russia
Key Responsibilities
Strategic
Formulate, lead and drive the regulatory strategy for new product submission & approval. Provide regulatory inputs during product ideation, product development, pharmaceutical studies, preclinical & clinical studies.
Active involvement in product development, regulatory submissions/approval & launch support for in-licensed products
Maintenance of existing registrations (post approval amendments & re-registrations) and handling of quality complaints
Foreseeing changes in regulatory environment, alerting the management about upcoming changes & aligning the product development, regulatory & manufacturing strategies accordingly.
Operational
Proactively coordinate & provide support to the country regulatory w.r.t. documents, answering deficiencies and arranging samples. Provide support for manufacturing facility audits, art-work approval process, trade dress approval process and pharmacovigilance.
Support & coordinate with SCM for product launches. Facilitate local manufacturing/re-packaging activities and IP coordination i.e., patents & trademarks.
Operating Network
Internal: Regulatory Affairs team, Biologics, In-Licence Partners, R&D, AR&D, IPM, Packaging Development, Manufacturing, Quality, SCM and Business Development
External: In-Licensing Partners, Regulatory Consultants
Technical Requirements: In depth understanding of pharmaceutical science and regulatory affairs. Knowledge of product development, analytical development, manufacturing & quality, Intellectual Property Rights (Patents & Trademarks), preclinical, Bio-equivalence & clinical studies.
Educational Qualifications: Post Graduation in pharmaceuticals is necessary.
Experience Required: Minimum of 7 years experience in pharmaceutical industry of which at least 4 years in a role handling regulatory affairs, preferably in Russia/CIS markets.
Key Personal Attributes
Demonstrates cross cultural sensitivity
Highly self driven with good relationship & influencing skills
Displays good leadership capability
Aptitude for and interest in learning new languages
Relocation Assistance to Moscow, Russia
Contact Details
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