Roche has established Global Analytics and Technology Center of Excellence (GATE) at Chennai to drive analytics and technology driven solutions by partnering with Roche affiliates across the globe. As an Analyst / Sr Analyst, you will work closely with stakeholders in the business teams across Roches global affiliates and deliver high quality analytics solutions to real-world business problems.
Post : Regulatory Affairs – India & Direct markets (Sri Lanka, Nepal and Bhutan)
Job Description
Strategy / Planning :
• Define regulatory strategy in co-ordination with global/local teams for early launch of new and subsequent new drugs in India as per the business needs. Collaborate with medical value, clinical, marketing, strategy, supply chain team for developing the regulatory strategy for new products.
• Strategic thinking & strategic analysis including competition to identify changing trends for future Roche submission for positive outcomes
• Oversee the execution of the strategy by team to submit and seek the approvals as planned with stakeholder mapping and engagement
• Ensure regulatory compliance for product released to market according to marketing authorizations
• Ensure effective Regulatory Affairs input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
• Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities.
• Gather, analyze and communicate internal and external regulatory intelligence
• Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DRA Management
• Keep a track on the development activities of competitors and communicate to the relevant departments of Affiliate on real time basis
• Ensure compliance to internal and global systems (IFTs and trackers)
• Update all internal local as well as global stakeholders on regulatory framework changes; Create procedures, trackers to facilitate working of team members; Allocate tasks within the team and provide leadership and director to team
• Interactions and engagement with Regional / Global colleagues and Distributors of Direct markets
Dossier preparation, review and submission
• Oversee timely and accurate submission of the applications to regulatory authorities as per the plan created; Liaise with regulatory authorities for seeking clarifications in case required;
• Proactively take steps/drive discussions on open issues with cross functional teams for obtaining the approvals as per the timelines that are projected;
• Follow up with team to respond to the queries in reasonable period of avoid delays in approvals
• Ensure robust and effective preparation for HA meetings (SEC)
Life Cycle management
• Follow up with team for submission of documents for license renewal; Review and give inputs during the preparation of submission, Check all variations are filed in timely manner to avoid any supply chain issues
Liaising with regulatory authorities
• Routine interactions with regulatory authorities for getting feedback, follow-up, resolving open queries, gather intelligence for effective planning and faster approvals
• Work for effective Roche India image
Policy shaping
• Work with Industry associations for new reforms / policy shaping
• Work with regulators for Policy shaping - ease of business, faster access, generics / biosimilar
• Work with Regional and Global Regulatory policy team to drive the policy shaping in India
• Work with Indian Pharmacopeia Commission for products entering IP
People development
• Participate in recruitment and induction of new employees in team
• Set objective goals and evaluate performance of team members
• Ensure appropriate Regulatory Affairs resources and budget are in place
• Recommend employees for promotions; Recommend reward and recognition programs for team
• Provide performance feedback, conduct development activities, coach and mentor the team
• Provide opportunities to the team to develop their capabilities
• Conduct regular team meetings to guide team on departmental issues
• Resolve issues faced by team; Identify and recommend retention plans for key team members
Eligibility Criteria
Qualifications : M.Pharm or equivalent degree, Higher degree and / or RA specialist accreditation desirable
Experience: Work Experience in years overall: 15+ years; Work experience relevant to the field: 10+ years
For internal hiring minimum 2 years with Roche Pharma
• Pharmaceutical medicine training highly desirable
• Knowledge of drug developments
• Knowledge of clinical trials
• Knowledge of manufacturing sites
• Knowledge of regulatory and statutory requirements
• Product knowledge
• Knowledge of GMP
• Knowledge of Quality Assurance
Additional Information
Experience : 5+ years
Qualification : M.Pharm or equivalent degree
Location : India
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th August, 2023
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