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Inviting applications for the role of Labelling Management Senior Associate

**Work Location: Hyderabad/Noida/Gurgaon The purpose of the Labelling Management Senior Associate position is to lead the development and update of global labeling strategies and corporate, US and EU labeling (prescribing information and patient information) on assigned portfolio for developmental and Life-Cyle Management (LCM) for Opella products assigned to obtain company and/or agency approval.

Development or update of labeling strategy for these products based on study results, literature or other information relevant to the product or product class in order to deliver a consumer-centric labeling and to meet with the business objectives.

Lead labeling review and approval, preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company.

Participate with affiliates in agency replies for local issues and to assure compliance with corporate labeling.

This position is at the Global company level, to support the Global business across all Opella Categories and Regions/countries.

The Labelling Mangement Senior Associate will build and maintain robust collaborative relationships with key internal stakeholders, including Regulatory Category leaders, Pharmacovigilance, Medical, Marketing, Innovation, Legal, and other functions key to the success of product LCM and commercialization.

The Responsibilities:





- Ensures preparation of/or prepares labeling strategy for Opella products based on study reports and labeling requirements worldwide resulting in completion of internal and external approved product labeling for Opella products.
- Ensures updates to/or prepares updates to labeling for Opella products considered as Life Cycle Management (LCM) products resulting in completion of internal and external approved product labeling for LCM products.
- Optimizes coordination of labeling review and approval throughout the E2E labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates, release of labeling for use throughout the company and deviation management.
- Chairs multi-discipline labeling working groups, presenting labeling proposals and reaching consensus on proposals resulting in presentation of labeling proposals to Corporate Labeling Review Committee, for internal approval of proposed labeling.
- Ensures preparation of/or prepares labeling for submission to regulatory agencies resulting in submission of labeling as part of Marketing Authorization Application or updates to Marketing Authorization Applications.

Experience:

- Experienced science affairs (Medical, Regulatory or R&D;) professional with knowledge of industry trends and experience in driving and implementing process improvement initiatives
- Labeling experience will be considered.
- Experience leading and managing teams, preferably global, and across functions.
- Experienced professional with knowledge of industry trends and experience in driving and implementing process improvement initiatives

Soft skills:

- Highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professionalism.
- Must be able to work with all levels of associates and direct management within the Company (domestic/international), and demonstrate good communication, interpersonal and organizational skills.
- Can identify challenges and take steps to resolve.
- Ability to assess complex issues and propose viable solutions
- Adaptability/Flexibility The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands




- Ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities,
- Ability to act as a Business Partner
- The ability to work co-operatively with others; to display a multicultural sensitivity in such a Global context and the genuine desire to be a part of a team and contribute to organizational and team goals.

Technical skills:

- Thorough industry training and familiarity with scientific communications and labelling is required.
- Knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products; knowledge of labeling requirements; proven ability to lead and develop direct reports; organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics.
- Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices.

Education:

- Bachelor's degree in Life Sciences field or Pharmacy preferred.

Why join Genpact?

- Be a transformation leader Work at the cutting edge of AI, automation, and digital innovation
- Make an impact Drive change for global enterprises and solve business challenges that matter
- Accelerate your career Get hands-on experience, mentorship, and continuous learning opportunities
- Work with the best Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
- Thrive in a values-driven culture Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
- Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
- Lets build tomorrow together.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

📌 Global Labelling (Gurugram)
🏢 Genpact
📍 Gurugram