Regulatory Affairs Specialist

3 weeks ago

mumbai, India Michael Page Full time
Opportunity to work with a leading European public health organization Best in-class industry experience and benefits

About Our Client

A United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for LMICs. Through its innovative business model, it partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.

Job Description

Regulatory activities:

Assume full ownership of the Regulatory Database development initiative, which focuses on regulatory requirements of different product categories (Generics, Biosimilars, Vaccines and IVDs) in LMICs. This includes: Collecting, interpreting, and verifying raw data for the Regulatory Database, as well as managing full project lifecycle until successful launch of the database Analysing, monitoring, and tracking the regulatory landscape across LMICs for the specified product categories and ensuring ongoing maintenance and update of the database Keeping abreast of changes to the guidelines from ICH, FDA, WHO-PQ, EMA and other stringent regulatory authorities. Engaging with regulators from different regulatory bodies to identify regulatory pathways for licensees.


In licensing:

Provide regulatory guidance to the scientific team to facilitate the identification and prioritization of suitable candidates for in licensing. Provide regulatory assessments of selected products for in-licensing. Contribute to the feasibility studies through facilitating consultation calls with potential partners to evaluate the partners' manufacturing and regulatory capabilities. In collaboration with in-licensing team develop a business case for the in-licensing of selected candidates. Provide regulatory inputs during license negotiations with the originator, and the finalization of terms of agreements.


Out licensing:

Participate in the Expression of Interest process and the selection of out licencing beneficiaries (generic manufacturers). Track and monitor development activities and regulatory filings by sublicensees. Ensure regular communications and exchange of information with sublicensees through participation in the quarterly meeting reviews (F2F and remote meetings with generic manufacturers). Proactively identify critical areas of concern and bottlenecks with respect to product registration and support the sublicensees with regulatory inputs to accelerate development and filing process. Support the Alliance Management team in fostering effective partnerships with both, sublicensees and originator companies.


Other Responsibilities:

Provide regulatory inputs to case studies within organization Engage with legal, policy and market access, technology transfer and communications teams providing necessary regulatory insights to support realisation of the mission and strategic objectives. Perform other duties as assigned by the supervisor or the senior management team.

The Successful Applicant

Essential

University degree in Pharmacy or any other related discipline with strong scientific/regulatory component. 10 + years of experience in pharmaceutical industry within regulatory affairs Solid understanding of the generic drug registration process with a special focus on developing countries (emergent markets). Demonstrated ability to manage multiple projects effectively. Well versed with the regulatory guidelines from ICH, FDA, EMA, WHO and other stringent regulatory authorities Native-level fluency in written and spoken English. Experience of working in a complex environment with a track record of accountability and execution.

Desirable

Knowledge of handling registrations of different product categories (small molecules, biologics, vaccines, etc) and different dosage form (solid oral, injectables etc). Knowledge of intellectual property and voluntary licensing Interest in public health and access to medicines in low resource settings. Good understanding of general NCE registration process.

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