Regulatory Affairs Associate III

5 days ago

Navi Mumbai, India Teva Pharmaceuticals Full time
Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunity
  • This position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of authoring clinical and non-clinical expert reports and summaries supporting new submissions of Teva’s portfolio (Generics, Innovative and Medis organizations) in international markets (IM).
  • Able to work with cross-functional, multidisciplinary teams to facilitate preparation of regulatory documents (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications)
How you’ll spend your day
  • Plan, author, review, and coordinate various regulatory documents.
  • Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
  • Lead briefing book preparation to support HA meetings for Innovative products, including process planning, authoring, comment resolution meeting (CRM).
  • Performs search and reviews relevant literature references related to efficacy, safety, drug-drug interaction studies, etc. in line with SmPC of the reference product (various therapeutic areas).
  • Prepares scientific overviews based on the available literature and in line with the regulatory requirements in the format of clinical and non-clinical expert reports and summaries to support Gx product regulatory submissions; prepares a.m. document updates.
  • Editorial reviewing of documents for grammar, punctuation, and submission-compliant formatting (TACT templates).
  • Cross-functional focal point for medical affairs issues raised through deficiency letters of Gx and innovative products in IM; writing high quality responses supported by literature findings.
  • Contributes to routine lifecycle management activities for a cross section of products – Generics, Biosimilars as well as innovative products.
  • Collaborates with other colleagues in Regulatory affairs, R&D and other departments as required.
  • Ability to perform under minimal supervision (if remotely located)
  • Maintain and enhance knowledge of regulatory guidelines, international regulations, and guidance associated with regulatory document preparation and submissions
Your experience and qualifications
  • Master's degree in life sciences or related scientific discipline with at least 7-8 years of pharmaceutical industry including some regulatory writing experience.
  • Qualification and experience for being final signatory for scientific expertise.
  • Ability to independently interpret and present scientific and medical information.
  • Proficient in use of Microsoft Office tools
  • Excellent knowledge of English language (oral and written)
  • Strong communication and interpersonal skills (oral and written)
  • Ability to work both independently and in cross-functional teams
  • Task oriented, ability to work according to targeted timelines
  • Well organized and self-disciplined with good planning skills
  • Good understanding of drug development.
  • Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability
Reports To

Director Regulatory Affairs

Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

  • Regulatory Affairs Associate III

    4 weeks ago

    Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityThis position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of authoring clinical and non-clinical expert reports and summaries supporting new submissions of Teva’s portfolio (Generics, Innovative and Medis organizations) in international markets...

  • Regulatory Affairs Associate III

    4 weeks ago

    Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityThis position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of authoring clinical and non-clinical expert reports and summaries supporting new submissions of Teva’s portfolio (Generics, Innovative and Medis organizations) in international markets...

  • Regulatory Affairs Associate III

    4 days ago

    navi mumbai, India Teva Pharmaceuticals Full time

    The opportunity This position provides medical and scientific expertise for regulatory submissions and implies in-depth expertise within medical science, with primary goal of authoring clinical and non-clinical expert reports and summaries supporting new submissions of Teva’s portfolio (Generics, Innovative and Medis organizations) in international...

  • Regulatory Affairs Associate III

    4 days ago

    Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

    Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines,...

  • Regulatory Affairs Associate

    2 weeks ago

    Goregaon, Mumbai, Maharashtra, India Zivira Labs Private Limited Full time

    _**Regulatory Affairs Associate**_ As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation. **Products include**: - Pharmaceuticals -...

  • Regulatory Affairs Associate

    2 weeks ago

    Mumbai, Maharashtra, India Planet Science Full time

    **About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

  • Regulatory Affairs Associate I

    4 weeks ago

    navi mumbai, India Teva Pharmaceuticals Full time

    The opportunity To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents...

  • Regulatory Affairs Associate I

    1 month ago

    Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityTo organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents and...

  • Regulatory Affairs Associate I

    2 weeks ago

    Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

    The opportunityTo organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents and...

  • Regulatory Affairs Associate I

    3 weeks ago

    navi mumbai, India Teva Pharmaceuticals Full time

    The opportunity To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents...

  • Regulatory Affairs Associate I

    4 weeks ago

    Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityTo organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application To ensure high quality documents and...

  • Regulatory Affairs Associate I

    5 days ago

    Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

    Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines,...

  • Regulatory Affairs Executive

    4 weeks ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...

  • Regulatory Affairs Associate I

    5 days ago

    Navi Mumbai, India Teva Pharmaceuticals Full time

    Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

  • Associate Manager, Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Kenvue Full time

    Associate Manager, Regulatory Affairs W Description Kenvue is currently recruiting for: Associate Manager, Regulatory Affairs This position reports to Director-Regulatory Affairsand is based at Mumbai. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of...

  • Regulatory Affairs Executive

    2 months ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: 319-54 Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** Category: Manufacturing **Job Description**: Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. They market wide range of poultry and cattle products. They are...

  • Regulatory Affairs Executive

    4 weeks ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....

  • Associate, Regulatory Affairs

    3 weeks ago

    Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 156756 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries...

  • .(Veterinary) Regulatory Affairs Executive for

    2 weeks ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai DESCRIPTION **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like State and Central FDA, DCI, etc. - Well conversant with Drug law/feed supplement regulation. - Co-ordination with factory, purchase department, marketing department. - Reviewing of technical...

  • Advisor, Regulatory Affairs

    2 months ago

    Mumbai, India Kimberly-Clark Full time

    The GRA **Advisor, Regulatory Affairs - APAC** provides vision, direction, and advice in the implementation of APAC regulatory strategies to ensure regional management of Consumer, Professional or enterprise innovation level regulatory compliance. The incumbent will strategize with, communicate, and advise business on anticipated and existing regulation and...