Shire RA Lead Russia in Moscow, Russia
Primary Duties .
The Manager, Regulatory Affairs Russia is responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.
Develop effective relationships with local commercial organization, distributors and service providers .
Provide effective liaison with the regulatory agencies in the region directly, through distributors contacts or service providers, ensuring escalation of key issues where required.
Provide regulatory guidance and advice on local country regulatory environments;
Provide assessment of the impact of new and changing regulations/requirements.
Use external resources to assist with the above tasks to not only meet timelines but expediting the time to market.
Job Function and Description
In collaboration with International RA Strategists, provide regulatory strategies to responsible functional groups and regulatory management.
Prepare and submit market applications, variations, post approval reporting obligations and general product life cycle management support.
Prepare and maintain project plans and timelines of approvals and planned submissions.
Prepare (as needed) and review key application components and meeting materials and chair/attend meetings with regulatory agencies and participate in agency inspections as required.
Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.
Interact with distributors; service providers and regulatory agencies to resolve related review questions
Act as a point of contact for the assigned projects and as interface with key corporate functional areas
Ensure compliance of regulatory activities in Russia consistent with Country laws and Shire internal protocols and procedures (CMLR, Labelling compliance, etc) in coordination and liaison with GRA labeling and Ad/Prom Groups
Develop relevant regulatory department local operating procedures (CMLR, etc)
Ensure regional regulatory documents, record keeping in secure, comprehensive manner
Ensure that all local product information used locally are up to date
Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements
Develop effective working relationships with business partners and service providers, including local visits as needed.
Support Regional RA Lead, Russia and CIS countries and International RA team on specific projects as requested.
Education and Experience Requirements
Science degree required, higher degree preferred.
At least 5 years regulatory experience in international regulatory affairs and/or drug development
Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility
Working experience in Russian regulation, relevant knowledge of bio/immune bio product registration, Custom Union regulation is an advantage
Key Skills, Abilities, and Competencies
Be pro-active, prioritise and able to work with minimal supervision.
Must be able to work in a fast paced environment with demonstrated ability to deal with competing tasks and demands.
High cultural awareness and sensitivity
Effective communication skills.
Critical thinking ability and good judgement
Fluent English, both written and Oral
Attentive to details
Complexity and Problem Solving
Makes most decisions independently and exercises strong judgment, leading to the resolution of complex regulatory/business issues, referring to Line Management where required.
Will make considered and strategic recommendations within the range of experience but seeks advice and/or guidance where the decision requires it.
Internal and External Contacts
The position reports to the Regional RA Lead , Russia and CIS countries.
Internal and external job contacts related to the position include project team members, cross functional teams, local and regional commercial senior management, regulatory agency personnel, and company consultants/business partners/distributors.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.