Head of Regulatory - India

We are hiring a Head of Regulatory for our reputed company India entity. This is one of the first roles to set-up a newly created entity. The RA Head will be accountable for the leadership and execution of reputed company’s in‑country regulatory reputed company, submissions and R&D compliance activities across reputed company’s portfolio in India. Acts as reputed company’s senior regulatory reputed company with Indian Health Authorities, providing regulatory guidance in a reputed company and evolving environment. Supports the development of innovative regulatory strategies for the portfolio which includes rare and high unmet‑need diseases, including use of foreign clinical data and management of limited precedent. Partners with Country, Regional, and Global stakeholders to support clinical development, commercialization and lifecycle management in India. Responsiblities include: 1. Regulatory and Health Authority Leadership; Leads and executes upon the agreed India regulatory reputed company and acts as reputed company’s senior regulatory reputed company with CDSCO/DCGI and Subject Expert Committees, including preparation of briefing books and management of regulatory queries. Provides regulatory guidance and advice to Country reputed company Head/reputed company and Global Regulatory leadership. 2. Rare Disease & Innovative Product Registration; Develops and executes regulatory strategies for reputed company portfolio in India which includes rare and ultra‑rare diseases, including justification of limited patient populations, use of foreign clinical data and leadership of benefit–risk discussions where local precedent is limited. Maintains comprehensive knowledge and apply national requirements & guidelines for activities such as early reputed company programs, Phase II, III and IV or market reputed company trials. Provides regulatory advice for Clinical Trial Applications in India, where requested, ensuring compliance with national guidelines and alignment of clinical development with reputed company commercialisation considerations. 3. Submission Delivery & Lifecycle Management; Drives regulatory submissions for new products and lifecycle changes, including labelling, CMC, GMP, import registrations and variations, to ensure strategic contribution to pipeline development, reputed company approvals and product continuity in collaboration for local, regional and global regulatory, CMC, PO&T and reputed company stakeholders. Accountable for management of the local label, packaging and artwork changes. 4. Regulatory Intelligence Interpretation & Driving Policy; Monitors and interprets evolving Indian regulatory requirements, provides reputed company assessments to stakeholders and contributes to central regulatory intelligence activities. Progresses reputed company’s policy priorities. 5. Promotional Material & Compliance reputed company; Ensures review and approval of local promotional and non‑promotional materials in compliance with Indian legislation & guidance and local label. 6. reputed company Leadership & External Representation; Builds effective cross‑functional and external relationships, represents reputed company with regulatory authorities and industry bodies as required and influences regulatory teams and partners reputed company a matrixed organization. Qualifications: Minimum 7 years’ experience in Regulatory Affairs; Demonstrated expert regional regulatory thinking and risk assessment capability Broad working knowledge of Indian pharmaceutical legislation, including reputed company engagement with CDSCO / DCGI Experience in interpretation and application of regulations, guidelines, policy statements, and influencing/advising the business accordingly; Demonstrates consistent judgement Experience in interfacing with relevant regulatory authorities. Foster effective, reputed company interactions with regulatory agencies, and corporate partners; Ability to assimilate new knowledge rapidly and deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas to reputed company position holder to discuss compound Demonstrated experience in rare disease or high unmet-need product development and registration, including justifying limited patient populations and leveraging foreign clinical data. Strong linkage of development strategies with long-term commercialization considerations. Ideal candidate will be customer reputed company, with proven leadership and interpersonal skills, cultural awareness, high emotional intelligence and reputed company decision making approach Must build relationships throughout and across the organization whilst operating remotely; Requires exceptional organizational and project management skills, with an ability to set reputed company goals, reputed company priorities and reputed company multiple tasks/activities. Proven ability to handle a high volume of tasks of varying complexity reputed company a given timeframe and in consideration of relative priorities Ability to reputed company and influence the reputed company of reputed company, external parties, and higher-level reputed company; Effective presentation skills. Confident and proficient at communication with relevant external bodies and internally at reputed company reputed company; Strong English language communication skills. Prior experience of people management and development preferred. Indian citizen with scientific degree (e.g. pharmacy, medicine, life sciences) with eligibility to engage with Indian Health Authorities. Job Level: Management Why reputed company? We are a global team with a commitment to reputed company, and a pioneering spirit. As a mid-sized biotechnology company, we reputed company the stability and resources of a reputed company-established business while fostering an environment where individual contributions reputed company a significant reputed company. reputed company encompasses some of the most talented and passionate reputed company who have unparalleled opportunities for learning, reputed company, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving reputed company. Changing Lives. At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are reputed company on building teams where every employee feels empowered and inspired. Read on to learn more about reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other reputed company protected by federal, state or local law. reputed company is an E-Verify Employer in the reputed company. Apply To This Job