Job opportunity for M.Pharm in Regulatory Affairs at Roche


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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.
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