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Job Description
Responsibilities of a Regulatory Affairs Manager :
Manages all the functions of the Regulatory Affairs Department including but not limited to
* Scheduling activities of the department.
a) Gathering of technical information from various sources.
b) Preparation of Dossiers, Submission of dossiers.
c) Preparation of applications to regulatory bodies for all necessary approvals. FDA, CDSCO, international regulatory bodies.
d) Review of dossiers of pharmaceutical products
e) Answering queries of regulatory bodies connected with product registration.
f) Overseeing of the regulatory process filing necessary applications and handling all government interactions.
g) Coordinating the inspection of the organization facilities and contract facilities, and developing procedures to ensure regulatory compliance.
h)Managing subordinate staff in the day-to-day performance of their jobs.
i) Ensuring that project/department milestones/goals are met while adhering to approved budgets.
k) Accompanying development projects and revising already existing technical documentations.
l) Communicating with responsible regulatory authorities (national/international) as well as with notified bodies.
m) Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of pharmaceuticals products and nutritional supplements.
n) Training team members to fulfill their job functions and improving their skills.
o) Staying informed about any changes in legislation etc.
Skills needed
1. Indian FDA guidelines knowledge
2. Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU.
3. Organizational Skills- Work assignment, time management, working within strict time frames.
4. Ability to solve regulatory queries & compliance matters.
5. 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 :
1) Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country.
2) Regulatory Affairs Manager – 5 + yrs experience in the related area as an individual contributor
3) Regulatory Affairs Executive /Officers – more than One year experience in Pharma Regulatory Affairs will be preferred
Desired Candidate Profile for Manager
Effective oral and written communication skills.
Must be flexible and capable of managing personnel
Must have a systematic approach to solving problems.
Must be able to keep calm and make quick, clear decisions while coping with pressure.
Must be able to understand the techniques and processes used
Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information.
Must be organized- timely, and with information/data.
Perks and Benefits
Salary not a constraint for the right candidate .
