Regulatory Affairs
13 hours ago
Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :
Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.
1. Dossier Preparation and Review
- Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Review dossiers prepared by team members to ensure they meet national and international standards.
- Provide guidance and technical expertise to the team during dossier preparation.
2. Regulatory Submissions and Approvals
- Manage applications for licenses, permissions, and other regulatory approvals in the country of manufacture and export destinations.
- Coordinate with relevant regulatory authorities to resolve queries and ensure timely approvals.
3. Task Management and Timeliness
- Ensure timely completion of departmental tasks, adhering to internal and external deadlines.
- Prioritize assignments and allocate resources effectively to maintain productivity.
4. Compliance Assurance
- Ensure that all regulatory guidelines are strictly adhered to during product manufacturing and export processes.
- Stay updated on changes in regulatory requirements and communicate updates to the team.
- Coordinating the inspection of the organization facilities and contract facilities and developing procedures to ensure regulatory procedures to ensure regulatory compliance
5. Team Leadership and Development
- Supervise and mentor the regulatory affairs team, fostering a culture of collaboration and accountability.
- Conduct performance evaluations, provide feedback, and identify training needs for team members.
6. Documentation and Reporting
- Maintain accurate records of all regulatory submissions and approvals.
- Prepare regular progress reports for senior management, highlighting achievements, challenges, and solutions.
Skills needed
- Indian FDA guidelines knowledge
- Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU.
- Organizational Skills- Work assignment, time management, working within strict time frames.
- Ability to solve regulatory queries & compliance matters.
- Knowledge of dossier types and filing requirements.
Responsibilities of a Regulatory Executives / Officers :
- To prepare and compile registration dossier as per the specific country guidelines and submit to regulatory authorities.
- To prepare, review compile re-registration documents.
- To prepare & review /check artwork, pack insert, SmPC etc.
- To study Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.
- To verify specification of excipients, active, finished product and packaging material and all required documents.
- Application, review, co-ordination, follow-up of legal documents COPP, FSC etc.
- Maintain Proper database w.r.t to master document dossier.
- To collect and verify all technical documents and information from various departments at the manufacturing site.
- Provide Regulatory support to various departments.
- Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose.
- To reply any queries raised by respective regulatory authority, in timely manner.
- To maintain and update Registration certificate /information in regulatory data base.
Requirement :
- Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country.
- Regulatory Affairs Manager years experience of working in the regulated markets
- Regulatory Affairs Senior Executive / Officers - more than Two years experience in Pharma Regulatory Affairs will be preferred
Required Candidate profile for Manager Level :
- Strong oral/written communication, leadership & problem-solving skills.
- Ability to stay calm under pressure and make quick decisions.
- Proficient in relevant techniques, processes, PC & internet research.
- Well-organized with timely data/information management.
-
Regulatory Affairs
3 days ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...
-
Regulatory Affairs Executive
1 day 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...
-
Regulatory Affairs Executive
1 day 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....
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full timeDesignation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head
-
Office Regulatory Affairs
3 days ago
Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...
-
Regulatory Affairs Executive
1 day ago
Mumbai, Maharashtra, India Fusion Market Research Full timeRegulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...
-
Regulatory Affairs
3 days ago
Andheri, Mumbai, Maharashtra, India The Hiring Experts Full time**Job Title: Regulatory Affairs for a reputed pharmaceutical company** 1. Review all technical documents for submission of ANDA submission and post-approval submissions. 2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies. 3. Preparation and review of pre-ANDA meeting packages, and controlled...
-
Regulatory Affairs Executive
3 days ago
Mumbai, India SourceGrids Consulting LLP Full timeOne of our key client is a leading pharmaceutical company headquartered in Mumbai is conducting interview drive for "Regulatory Affairs Executive" role at Dadar office. Interview date and timing - 2nd August'23 between 2 to 5 PM Job role - Regulatory Affairs Executive Experience - 3+ Years Job location - Dadar East, Mumbai Industry - Pharmaceutical /...
-
Regulatory affairs associate
4 weeks ago
Navi Mumbai, India Peoplefy Full timeWe're Hiring: Regulatory Affairs – CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...