6 Regulatory Writing jobs in India

**Our Team:**
_Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally._
**Main responsibilities:**
_Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews._
_Essential Job duties and responsibilities: 1)_ _Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers' writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned._
+ _People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise._
+ _Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts,_ _posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT_ _) as per agreed timelines and quality_
· _Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8)_ _Remain abreast of Sanofi Policy or Quality Documents evolution._
· _Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables._
About you
· **Experience** : _>5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry_
+ _Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts,_ _posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT_ _) as per agreed timelines and quality_
· **Technical skills** : _As applicable (Including but not limited to_ _Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills,_ _data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications_ _)_
+ _Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts,_ _posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT_ _) as per agreed timelines and quality_
· **Languages** : _Excellent knowledge of the English language (to read, write, and speak)_
**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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (

**Job Description**
Let's do this. Let's change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.
**Roles & Responsibilities:**
+ Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;
+ Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
+ With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications;
+ Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
+ May provide functional area input for Global Regulatory Plan and team goals
+ May work with contract and freelance writers
+ May participate in training and mentoring of junior medical writers
+ May participate in departmental and cross-departmental initiatives, as appropriate.
+ Generate document timelines, with team input
+ Keep abreast of relevant professional information and technology
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ 9-13 years of directly related experience
**Preferred Qualifications:**
**Functional Skills:**
+ Proficiency with word processing and other Microsoft Office Programs
+ Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;
+ Ability to understand and follow complex standard operating procedures (SOP's), guidance documents, and work instructions;
+ Understanding and application of principles, concepts, theories and standards of scientific/technical field.
+ Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance's and requirements.
**Soft Skills:**
+ Excellent written/oral communication skills and attention to detail
+ Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;
+ Proficient time and project management skills.
+ Self-starter with a drive and perseverance to achieve results
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**

Our Team:

Main responsibilities:

·

·

About you

·Experience :

·Technical skills :

·Languages :

Pursue , discover

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our and check out our Diversity Equity and Inclusion actions at !

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better – join our team today!

Your Role:

The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drugs with global regulatory agencies. This role also executes CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions.

Your Responsibilities:

• Design/develop CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
• Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing
• Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco
• Lead CMC submission preparation to provide high quality submissions to multiple geographies
• Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams
  
  

What You Need to Succeed (minimum qualifications):

• Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
• 5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management
• Understanding of the cGMP requirements
• Experience working with Regulatory Information Management Tools and Systems
  
  

What will give you a competitive edge (preferred qualifications):

• Strong knowledge of FDA/CVM and EMA guidelines
• Experience with CMC registrations in the US and/or Europe
• Strong communication skills, both written and oral
• Ability to make decisions when there is no clear right or wrong answer
• Self-starter, takes initiative
• Timeline driven
• Attention to detail
• Quality and customer focused mindset
• Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time
  
  

Additional Information:

• Travel percentage up to 10%, annually.
• Location: IN, Bangalore - Hybrid Work Environment
  
  

Don't meet every single requirement Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don&apost necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Skills Required
Regulatory Information Management Tools and Systems, CMC Regulatory Strategy, EMA Guidelines, cGMP Requirements, Global Regulatory Affairs

Responsibilities:

Design/develop CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance

Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing

Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco

Lead CMC submission preparation to provide high quality submissions to multiple geographies

Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams

What You Need to Succeed (minimum qualifications):

Degree in Science (MSc, B. Pharm/, Postgraduate in Vet Sciences etc.,) 

5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management

Understanding of the cGMP requirements

Experience working with Regulatory Information Management Tools and Systems

What will give you a competitive edge (preferred qualifications):

Strong knowledge of FDA/CVM and EMA guidelines

Experience with CMC registrations in the US and/or Europe

Strong communication skills, both written and oral

Ability to make decisions when there is no clear right or wrong answer

Self-starter, takes initiative

Timeline driven

Attention to detail

Quality and customer focused mindset

Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time

Additional Information:

Travel percentage up to 10%, annually.

Location: IN, Bangalore - Hybrid Work Environment

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!