Thursday 27 June 2013

Regulatory Affairs Manager (Russia)

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


Contact Details
Recruiter Name:
Chetan Budhia
Email Address:

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