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Roche Jobs in Regulatory Affairs Department 2023

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Roche Jobs in Regulatory Affairs Department 2023, Roche has established the Global Analytics and Technology Center of Excellence (GATE) at Chennai to drive analytics and technology-driven solutions by collaborating with Roche affiliates across the globe. As an Analyst/Senior Analyst, you will work closely with stakeholders in the business teams across Roche’s global affiliates and deliver high-quality analytics solutions to real-world business problems.

Roche Jobs in Regulatory Affairs Department 2023

Roche Jobs Job Card 2023

PostRegulatory Affairs – India & Direct markets (Sri Lanka, Nepal and Bhutan)
Experience15+ years/ Work experience relevant to the field of 10+ years
QualificationM.Pharm or equivalent degree/ Higher degree, and/or RA specialist accreditation desirable.
Last Date30th August 2023
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Job Description: Strategy / Planning:

  • Define regulatory strategy in coordination with global/local teams for the 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 to develop the regulatory strategy for new products.
  • Conduct strategic analysis, including competition analysis, 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, such as market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, and legal issues.
  • 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 submission strategies for Affiliate products with limited guidance from DRA Management.
  • Monitor the development activities of competitors and communicate real-time updates to relevant departments of the Affiliate.
  • Ensure compliance with internal and global systems (IFTs and trackers).
  • Keep all internal local and global stakeholders informed about regulatory framework changes.
  • Create procedures and trackers to facilitate the working of team members.
  • Allocate tasks within the team 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.
  • Liaise with regulatory authorities to seek clarifications when required.
  • Proactively drive discussions on open issues with cross-functional teams to obtain approvals as per projected timelines.
  • Follow up with the team to respond to queries promptly to avoid delays in approvals.
  • Ensure robust and effective preparation for Health Authority 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:

  • Regularly interact with regulatory authorities for feedback, follow-up, resolving queries, and gathering intelligence for effective planning, and faster approvals.
  • Work to establish an effective Roche India image.

Policy Shaping:

  • Collaborate with industry associations for new reforms and policy shaping.
  • Work with regulators for policy shaping related to ease of business, faster access, generics, and biosimilars.
  • Collaborate with Regional and Global Regulatory policy teams to drive policy shaping in India.
  • Work with the Indian Pharmacopoeia Commission for products entering IP.

People Development:

  • Participate in recruitment and induction of new employees in the team.
  • Set objective goals and evaluate the performance of team members.
  • Ensure appropriate Regulatory Affairs resources and budget are in place.
  • Recommend employees for promotions and propose 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 the team 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 of 15+ years; Work experience relevant to the field of 10+ years.
  • For internal hiring, a minimum of 2 years with Roche Pharma.
  • Pharmaceutical medicine training is highly desirable.
  • Knowledge of drug developments, clinical trials, manufacturing sites, regulatory and statutory requirements, product knowledge, GMP, and 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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