GRA Labelling Specialist

Biopharma Careers; Hyderabad; Hybrid; INR 1,200,000 - 2,400,000; Full time

Job summary

Sanofi in Hyderabad, India, seeks a GRA Labelling Specialist to drive labeling value and support regulatory strategy for marketed and lifecycle products. The role operates in a hybrid model and requires leadership in cross-functional labeling discussions and regulatory submissions.

You will prepare labeling components (CCDS, USPI, EU SmPC), coordinate reviews, and ensure timely, compliant deliverables across regions. Strong English, regulatory literacy, and project management are essential.

Qualifications

• Knowledge of labeling principles (CCDS EU, US) and ability to coordinate discussions across multi-functional groups.
• Ability to read and interpret HA regulations and guidances and SOPs.
• Experience in preparing labeling components for regulatory submissions and negotiations.
• Strong organizational and project management skills for multi-project handling.
• Fluent business English and effective written/verbal communication.

Responsibilities

• Prepare/update labeling documents (CCDS, USPI, EU SmPC) and patient text for marketed/lifecycle products.
• Coordinate labeling review/approval through end-to-end process; prepare components for regulatory submissions.
• Support cross-functional teams as labeling expert and contribute to global regulatory strategy.
• Maintain and ensure compliance of Marketing Authorizations; participate in health authority discussions.
• Lead labeling working groups, present proposals, and drive consensus for senior governance approval.
• Meet submission timelines and quality standards for labeling deliverables.
• Develop labeling proposals for internal approval and respond to health authority questions.

Skills

Labeling knowledge

Regulatory affairs knowledge

Cross-functional coordination

Excellent communication

Project management

Education

Bachelor’s degree in Life sciences or related

Tools

Regulatory databases

Job description

Job title: GRA Labelling Specialist

Location : Hyderabad, India (Hybrid Model)

About the job

Our Team: Drive Labeling Value to maximize Sanofi´s competitive advantage

Main responsibilities

• Prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products for company and/or agency approval.
• Coordination of labeling review and approval throughout the E2E labeling process, which includes 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 for mature/marketed products.
• Support cross-functional teams (LWG) as a labeling expert and contribute to the global regulatory strategy and to the preparation of of labeling components of submission dossiers or responses to Health Authorities…
• For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work sharing, PRAC questions (signal detection))
• Anticipates any hurdles and informs manager as appropriate
• Coordinate and create the presentation of labeling proposals to be presented to Senior Executive Management via Labeling Review Committee
• Perform labeling competitive/comparator analysis
• Meet established submission timelines and quality standard for labeling deliverables
• Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.

About you

Experience: Knowledge of the principles and concepts of Labeling (including generics), and the dynamics of Labeling Team purpose and objectives.

Knowledge of labeling requirements for drugs (CCDS EU, US); organizational and networking skills; and ability to coordinate discussions across a multi-functional group (LWG) to reach resolution on labeling topics.

Ability to read and interpret HA regulations and guidances, and relevant company SOPs.

Ability to connect regulatory strategy into labeling strategy

Ability to work autonomously for routine tasks but needs oversight on more complex topics (as needed)

Ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC…), provide labeling strategy proposal, negotiate, resolve conflict and build consensus.

Must be able to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling

Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc…)

Soft skills: Excellent written and verbal communication skills, networking skills.

Situational awareness, problem solving skills.

Organizational skills, ability to manage multiple projects at short notice.

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.

Defined experience requirement: 3–5 years of relevant industry or functional experience.

Technical skills: Highly detail oriented, strong analytical and organization skills, project management skills, self-starter, critical thinking required, ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics. Ability to build/learn scientific knowledge (e.g. statistics, disease area).Ability to search for public data on labeling elements (enabling digital capabilities)

Education: Bachelor’s degree in Lifesciences or equivalent, with 3 plus years of related work experience in Regulatory Affairs/Labeling or equivalent in highly regulatory environment

Languages: Fluent business English.

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !