Regulatory Affairs Specialist
2 weeks ago
Why Patients Need You
Pfizer is committed to bringing medicines to the world faster, without compromising on excellence and integrity. To achieve this, we need a dedicated team of regulatory experts who can navigate the complex regulatory landscape and ensure compliance with local and global regulations. As a Regulatory Affairs Specialist, you will play a critical role in providing strategic product direction to teams, interacting with regulatory agencies, and negotiating to expedite approval of pending registrations.
What You Will Achieve
You will be responsible for representing Pfizer as an approval liaison in the regulatory affairs team, providing regulatory support to cross-functional teams, and participating in technical reviews and strategic discussions on regulatory submissions. Your expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
How You Will Achieve It
- Contribute to the completion of project milestones and organize your work to meet project task deadlines.
- Ensure compliance of the team to the submission standards, procedures, and policies framed by Global Regulatory Affairs.
- Prepare and finalize Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements/variations for Lifecycle Management (LCM) submissions, and ensure effective data presentation and quality.
- Provide regulatory support to cross-functional teams for assigned products, participate in technical reviews, and provide inputs in strategic discussions on regulatory submissions.
- Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.
- Identify and assess regulatory risks associated with assigned projects and communicate them to the team to quickly mitigate the risks.
- Liaise with key stakeholders to ensure filing strategies are defined and executed, and Board of Health (BoH) requirements are met, ensuring a submission-ready dossier.
- Ensure commitments made to health authorities are entered into tracking systems and are tracked to closure.
- Manage continuous improvement of selected processes relating to Human health submissions and selected drug and non-drug specific projects and related activities.
- Ensure timely approval according to product registration plan.
- Maintain the required regulatory databases to ensure compliance.
- Keep abreast of the external regulatory environment, including competitor intelligence, local product, and international regulatory and commercial strategies.
-
Regulatory Affairs Specialist
1 week ago
Chennai, Tamil Nadu, India Pfizer Full timeRegulatory Affairs Specialist Job DescriptionAt Pfizer, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a key role in the preparation, publication, tracking, and quality control of our submissions to regulators in compliance with document management standards.Key...
-
Regulatory Affairs Specialist
1 week ago
Chennai, Tamil Nadu, India TTK Healthcare Full timeJob Title: Regulatory Affairs SpecialistTTK Healthcare is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our orthopedic implant products.Key Responsibilities:Technical writing, literature search,...
-
"Regulatory Affairs Specialist"
6 days ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeOverviewInternational Flavors & Fragrances is seeking a Regulatory Affairs Specialist to join our Global Regulatory Affairs team. As a key member of our team, you will be responsible for providing support to our regulatory and commercial colleagues to ensure a timely and accurate experience in regulatory and customer document...
-
Regulatory Affairs Specialist
4 days ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need Regulatory Affairs Experts At Pfizer, we are committed to bringing medicines to the world faster and with excellence and integrity. A key part of this commitment is our Regulatory Affairs team, who work tirelessly to ensure that our products meet the highest standards of quality and safety. As a Regulatory Affairs Specialist, you will...
-
Regulatory Affairs Specialist
2 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeJob SummaryPfizer is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and timeliness of submissions to regulatory authorities.Key ResponsibilitiesCoordinate CMC change management...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need YouWe're committed to bringing medicines to the world faster, without compromising on excellence and integrity. To achieve this, we need dedicated professionals who can navigate the complex regulatory landscape. As a Regulatory Affairs Specialist at Pfizer, you will play a critical role in ensuring compliance with local and global...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and managing CMC change management processes.Key ResponsibilitiesPartner with internal and external partners to confirm...
-
Regulatory Affairs Specialist
2 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need YouPfizer is committed to delivering innovative medicines and vaccines to patients worldwide. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the approval of our products in various markets. Your expertise in regulatory procedures, combined with your ability to communicate effectively with...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India TTK Healthcare Full timeJob Title: Executive – Regulatory AffairsReporting to: Assistant Manager – Regulatory AffairsDivision: Ortho ImplantsLocation: ChennaiNo. of Positions: 1Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory AffairsExperience: 2 - 4 years Exp. in 'scientific writing / clinical documentation' role preferredKey Responsibilities:Technical...
-
Senior Specialist
1 week ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeGlobal Regulatory Affairs Team MemberWe are a global leader in taste, scent, and nutrition, offering our customers a broader range of solutions for the food & beverage industry.As a Senior Specialist, Regulatory Business Operations, you will support the broader Global Regulatory Affairs function with deriving value from data and processes. You will help...
-
Senior Specialist
5 days ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeJob Title: Senior Specialist - Global Regulatory AffairsAbout the RoleWe are seeking a highly skilled Senior Specialist to join our Global Regulatory Affairs team at International Flavors & Fragrances. As a Senior Specialist, you will play a critical role in supporting the Global Regulatory Affairs function with deriving value from data and processes.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the timely and accurate submission of regulatory documents to various health authorities around the world.Key ResponsibilitiesCoordinate and manage CMC change...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pfizer. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and managing the submission process for our products.Key ResponsibilitiesPartner with internal and external partners to confirm the...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need YouWe're committed to bringing innovative medicines to patients faster, while maintaining the highest standards of excellence and integrity. Adhering to local and global regulations is crucial, and our team is dedicated to staying ahead of the ever-changing regulatory landscape. Your expertise will help expand and accelerate patient access...
-
Regulatory Affairs Specialist
3 weeks ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need YouWe're committed to bringing medicines to the world faster, without compromising on excellence and integrity. Adhering to local and global regulations is essential, and our ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to...
-
Regulatory Affairs Specialist
6 days ago
Chennai, Tamil Nadu, India Pfizer Full timeWhy Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...
-
Regulatory Affairs Associate
5 days ago
Chennai, Tamil Nadu, India Pfizer Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Pfizer. As a key member of our Regulatory Affairs department, you will be responsible for supporting the preparation, publication, and tracking of submissions to regulatory authorities in compliance with document management standards.Your ResponsibilitiesYou will...
-
Regulatory Business Operations Specialist
5 days ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeJob Title: Regulatory Business Operations SpecialistJob Summary:We are seeking a highly skilled Regulatory Business Operations Specialist to join our Global Regulatory Affairs team. The successful candidate will provide support to our regulatory and commercial colleagues to ensure timely and accurate experience in regulatory and customer document...
-
Senior Specialist
3 weeks ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeJob Title: Senior Specialist - Regulatory Business OperationsJob Summary:We are seeking a highly skilled Senior Specialist to join our Global Regulatory Affairs team. As a Senior Specialist, you will play a key role in supporting the broader Global Regulatory Affairs function with deriving value from data and processes. You will help design and implement AI...
-
Senior Specialist
3 weeks ago
Chennai, Tamil Nadu, India International Flavors & Fragrances Full timeJob Title: Senior Specialist - Regulatory Business OperationsJob Summary:We are seeking a highly skilled Senior Specialist to join our Global Regulatory Affairs team. As a Senior Specialist, you will play a key role in supporting the broader Global Regulatory Affairs function with deriving value from data and processes. You will help design and implement AI...
