Senior Regulatory Affairs Manager Biocon Biologics Limited

14.0 - 18.0 years

11 - 21 Lacs

bengaluru

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We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. • Support product registrations, renewals & variations. • Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. • Respond to health authority queries in coordination with CMC, clinical, and quality teams. • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. • Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. • Experience working with local affiliates or partner companies in Emerging Markets. • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. • Experience with regional electronic submission platforms. Qualifications: • Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or related field. • Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. • Knowledge of CTD structure, Module 1 customization, and regional submission formats. • Strong project management, communication, and stakeholder coordination skills

Posted 1 day ago

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Manager-Emerging Market Jiostar

7.0 - 12.0 years

12 - 22 Lacs

bengaluru, mumbai (all areas)

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Job Summary The Emerging Market Ad sales team caters to the mid-tier and emerging clients across categories and works closely with them to solve their marketing goals through custom solutions on JioStar. Our team works closely with the clients to understand their business and marketing goals and then provide solutions across the vast landscape of the JioStar ads ecosystem, which work for the client and also help secure ad revenues for JioStar as a platform. Key Responsibilities You will be driving sales & adoption of JioStar across emerging markets, executing a strategic business plan focused on new business development. Success will be measured on the value and number of advertisers on the platform Identifying and onboarding new advertisers, end to end account management and expansion in the assigned region End-to-end management of hunting, pitching, solutioning and execution for a large number of emerging/New age businesses Increase market share utilizing a consultative sales approach, competitor analysis, category level insights, emerging tech solutions and opportunities Unearthing new sales opportunities through networking and turning them into long- term partnerships Ability to act as an advisor on brand solutions in a strategic way and drive business Skills & Attributes for success Preferably experience from Ad sales background in TV/ Digital who has worked in this market and has connected with key clients and agencies Hands-on experience with CRM software and MS Excel Excellent interpersonal skills Strong analytical and organizational skills Numerical abilities and problem-solving attitude Abreast of current and upcoming trends among brands and the industry Preferred Education & Experience Graduate/ post graduate with 6-8 years of experience in sales, business development, account management and client relationship management with an understanding of digital sales background

Posted Date not available

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