About Roche
Roche has taken a significant step forward by creating the Global Analytics and Technology Center of Excellence (GATE) in Chennai. This center is dedicated to propelling analytics and technology-driven solutions through collaborations with Roche affiliates worldwide. As an Analyst / Sr. Analyst, your role will involve close collaboration with stakeholders from various business teams across Roche’s global affiliates. Your primary objective will be to provide top-notch analytics solutions to address real-world business challenges effectively. By leveraging cutting-edge technologies and data-driven insights, you’ll play a crucial role in driving Roche’s business success and contributing to advancements in the healthcare industry.
Post: Regulatory Affairs – India & Direct Markets (Sri Lanka, Nepal, and Bhutan)
Job Description
Strategy / Planning:
- Define regulatory strategy in coordination with global/local teams for early launch of new and subsequent new drugs in India as per business needs.
- Collaborate with medical value, clinical, marketing, strategy, and supply chain teams for developing regulatory strategy for new products.
- Conduct strategic analysis, including competition, to identify changing trends for future Roche submissions for positive outcomes.
- Oversee the execution of the strategy by the team to submit and seek approvals as planned, with stakeholder mapping and engagement.
- Ensure regulatory compliance for products released to the market according to marketing authorizations.
- Provide effective Regulatory Affairs input into cross-functional Affiliate business strategies.
- Ensure regulatory inspection-readiness for the Affiliate.
- Gather, analyze, and communicate internal and external regulatory intelligence.
- Develop innovative, risk-based registration plans and submission strategies for Affiliate products with limited guidance from DRA Management.
- Monitor competitors’ development activities and communicate real-time updates to relevant departments within the Affiliate.
- Ensure compliance with internal and global systems (IFTs and trackers).
- Update all internal local and global stakeholders on regulatory framework changes.
- Create procedures and trackers to facilitate the team’s workflow, allocate tasks, and provide leadership and direction to the team.
- Interact and engage with Regional / Global colleagues and Distributors of Direct markets.
Dossier preparation, review, and submission:
- Oversee timely and accurate submission of applications to regulatory authorities as per the plan created.
- Liaise with regulatory authorities for seeking clarifications when required.
- Proactively drive discussions on open issues with cross-functional teams to obtain approvals within projected timelines.
- Follow up with the team to respond to queries promptly to avoid delays in approvals.
- Ensure robust and effective preparation for HA meetings (SEC).
Life Cycle Management:
- Follow up with the team for submission of documents for license renewal.
- Review and provide inputs during the preparation of submissions.
- Ensure all variations are filed in a timely manner to avoid any supply chain issues.
Liaising with Regulatory Authorities:
- Maintain routine interactions with regulatory authorities to get feedback, follow up, resolve open queries, gather intelligence for effective planning, and obtain faster approvals.
- Work towards building an effective Roche India image.
Policy Shaping:
- Collaborate with industry associations for new reforms and policy shaping.
- Engage with regulators for policy shaping related to ease of business, faster access, generics, and biosimilars.
- Work with the Regional and Global Regulatory policy team to drive policy shaping in India.
- Collaborate with the Indian Pharmacopeia Commission for products entering IP.
People Development:
- Participate in recruitment and induction of new team members.
- Set objectives and evaluate performance of team members.
- Ensure appropriate Regulatory Affairs resources and budget are in place.
- Recommend employees for promotions and design reward and recognition programs for the team.
- Provide performance feedback, conduct development activities, coach, and mentor the team.
- Provide opportunities for the team to develop their capabilities.
- Conduct regular team meetings to guide them on departmental issues.
- Resolve issues faced by the team and 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: Overall work experience in years: 15+ years; Work experience relevant to the field: 10+ years. For internal hiring, a minimum of 2 years with Roche Pharma.
- Pharmaceutical medicine training highly desirable.
- Knowledge of drug developments, clinical trials, manufacturing sites, regulatory and statutory requirements, product knowledge, GMP, and Quality Assurance.
Additional Information
- Experience Required at Roche: 5+ years.
- Qualification Required at Roche: M.Pharm or equivalent degree.
- Location: India.
- Industry Type: Pharma.
- Functional Area at Roche: Regulatory Affairs.
- End Date: 30th August 2023.
To apply for this job please visit careers.roche.com. And Also Apply -Apply
