Regulatory Affairs Executive

Responsible for collating and compiling the dossiers for filing in different International markets like Africa, Asia, Latam, CIS & EU markets as per Relevant Regulatory guidelines of Pharmaceutical dosage forms like Tablets/Capsules/Dry syrup/Liquid syrup/Sterile Injectables (powder & liquid) /Ophthalmic/Semi solid preparations. Co-ordinating with...

Job Title: Regulatory Affairs BA Position: Software Engineer Experience: 3- 7 Years Category: Software Development/ Engineering Main location: India, Karnataka, Bangalore Employment Type: Full Time **Insights you can act on** While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business...

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...

We are hiring for dynamic individuals in Regulatory Affairs Department:Experience: 3 years up to 12 yearsDesignation: Senior Exec / Assistant Manager / Deputy ManagerQualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority...

We are hiring for dynamic individuals in Regulatory Affairs Department: Experience: 3 years up to 12 years Designation: Senior Exec / Assistant Manager / Deputy Manager Qualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority queries....

Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to Role:Join our International Regulatory Affairs team at AstraZeneca, where we are dedicated to delivering groundbreaking medicines to patients globally as efficiently as possible. An exciting opportunity awaits for a Regulatory Affairs Manager II. This role involves overseeing planning,...

Job Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, bold approaches are taken to bring crucial medicines to patients globally. The focus is on accelerating Regulatory approvals for new medicines efficiently so that no...

**Job Title: Regulatory Affairs Associate I** **Career Level - C** **Introduction to Role**: **Accountabilities**: As a Regulatory Affairs Associate, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain...

**Key Accountabilities**: **Project Administration**: - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide...

Provide responses to regulatory agencies regarding product information or issues. - Train RA Assistant and staffs in regulatory policies or procedures. Coordinate internal discoveries and depositions with legal department staff. - Develop and maintain standard operating procedures or local working practices. - Establish regulatory priorities or budgets and...

**Job Description** Regulatory Affairs BA Position Description Requirement Regulatory Affairs BA Recruiter Name Nikitha Njoyn ID J1122-2759 Primary Skills Regulatory Affairs BA Secondary Skills Pharma Domain Experience 3-6+yrs Notice Period 0-30days Location Bangalore/ Hyderabad Detailed Job Description Technical Skills: - Regulatory Affairs - 3+...

Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work...

Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work...

Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to role:The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The Regulatory Affairs...

**Job Title: Regulatory Affairs Associate I (International Regulatory Affairs)** **Career Level - C** **Introduction to Role**: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...

**Responsibilities**: - Work closely with Engineering team through product development process and design activities - Author/participate in the design validation and process validations, IQ, OQ, PQ. - Prepare, review risk management files and support risk management activities including hazard analysis and FMEA. - Identify relevant guidance documents,...

Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our dynamic International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients across the globe. We have an exciting opportunity for a Regulatory Affairs Manager I to contribute to our mission. In this role, you will be...

Job Title: Regulatory Affairs Associate ICareer Level - CIntroduction to Role:Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role offers an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory Affairs...

Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...