Regulatory Affairs Associate Director
1 month ago
The Regulatory Affairs Vaccines Therapeutic Group is looking for a new team member to join and work on one of our accelerator projects.
The purpose of this team is to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labelling to meet the Asset Profile, commensurate with the available data
Responsibilities and Accountabilities:
You are accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency. Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, you will be responsible for:
Proactively developing regulatory strategy, considering the needs of other regions globally.
Implementation of the regional strategy(s) in support of the project globally
Lead regulatory interactions and the review processes for assigned asset strategy
Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable
Ensuring compliance with global/ regional requirements at all stages of product life cycle.
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.
Why you?
Experience, Skills and Specialized Knowledge Required
Degree in biological or healthcare science
Experience in Early activities and launch of Phase I and II, experience of all phases of the drug development process in Regulatory Affairs preferred
Capable of leading regulatory development, submission, and approval activities in assigned region(s)
Knowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.
Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
Competencies and Capabilities:
Good communication skills, especially written communications. Capable Skilled at delivering key communications effectively with clarity, impact, and passion
Ability to foster strong matrix working and develops strong networks. Facilitates dialogue between team and matrix members to contribute their ideas.
Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
Capable of developing and recommending strategies for change.
Capable of identifying long term project or team issues in advance and seeking necessary help and support to resolve.
Ability to take sound decisions and in doing so, will use a range of sources and weigh benefits and risks before making important decisions.
Challenges and questions ways of working to seek improved processes. Seeks to raise levels of performance by establishing or improving processes.
#Li-GSK
#GSKVaccines
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
We have other current jobs related to this field that you can find below
-
Mumbai, Maharashtra, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. ...
-
Associate Director Regulatory Affairs Biosimilars
3 months ago
Mumbai, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...
-
mumbai, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. ...
-
Mumbai, India Abbott Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...
-
Associate Manager, Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Kenvue Full timeAssociate 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...
-
Director Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Abbott Full timeCORE JOB RESPONSIBILITIES Primary Function/Primary Goals/Objectives : Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation. Develop and supervise regulatory professionals. Have department level influence and be generally recognized as an expert...
-
Mumbai, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
Mumbai, Maharashtra, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
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 -...
-
Advisor, Regulatory Affairs
2 months ago
Mumbai, India Kimberly-Clark Full timeThe 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...
-
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 Executive
4 weeks ago
Mumbai, India Morpheus Human Consulting Full timeReference 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...
-
Assoc. Dir., Regulatory Affairs Cmc
1 week ago
Mumbai, India MSD Full time**Associate Director, Regulatory Affairs CMC** The Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance’s, and our company's procedures. Would also lead the preparation and submission of CMC dossiers for life-cycle changes to...
-
Regulatory Affairs Executive
2 months ago
Mumbai, India Morpheus Human Consulting Full timeReference 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 timeReference 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 timeRelocation 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...
-
Regulatory Affairs Associate III
6 days ago
Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full timeWho 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 III
7 days ago
Navi Mumbai, India Teva Pharmaceuticals Full timeWho 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...
-
.(Veterinary) Regulatory Affairs Executive for
2 weeks ago
Mumbai, India Double HR Consultancy Full timeMumbai 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...
-
Female - Urgent: Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Double HR Consultancy Full timeFemale - Urgent: Regulatory Affairs Executive(Female)/ Pharmaceutical Mumbai, Vile Parle Share VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing...
