Colgate-Palmolive Pharmacy Recruitment – Online Applications Invited
Colgate-Palmolive Pharmacy Recruitment – Online Applications Invited. Indian nationals are encouraged to apply online for an Associate – Regulatory Affairs vacancy at Colgate-Palmolive. Colgate-Palmolive Careers in 2021. It is an online application process:
Colgate Job Details
Job Title: Associate – Regulatory Affairs
Job ID: # 98088
Location: Mumbai, Maharashtra, India (Remote working option during the current situation. Relocation Assistance Offered Within Country)
We are seeking Associate– Regulatory Affairs to join our team at our Global Technology Centre in Mumbai. Reporting to Team Lead– North America, EU & APAC, you will certainly be accountable for assisting with the regulatory operational activities of global development programs, providing regulatory support for worldwide registrations. Likewise maintenance of products throughout the life-cycle mainly for medicinal products and also medical devices, as well as any other category of products, for the European Division.
- Work closely and support Regional Regulatory Affairs programs as well as activities for new product registration as well as life-cycle management of CP portfolio. Including and also not limited to, product renewals, variations, notifications and/or new license applications.
- Support the regulatory strategy defined at the Regional and/or Global level, and report regularly the progress to Regional RA Department with relevant important metrics.
- Especially in terms of timelines, the status of encouraging data required from various other functions and dossier preparation.
- Compile documents and data required for high quality and also successful submissions, license renewals and also annual registrations, and also maintenance of product registration dossiers for authorities.
- Work with the Regional Department in preparing submissions to Proficient Authorities and also Notified Bodies, guaranteeing timely approval of new products and life-cycle submissions.
- Notify Regional Manager of upcoming renewals as well as commitments promptly as well as inform the tracking of outstanding documents
- Upload and also publish the electronic Common Technical Document (eCTD) series for medicinal products. Work closely with Global and also European functions to acquire the relevant documents and also information for product dossiers.
- Aid in the prep work of Regulatory Standard Operation Procedures, and in keeping track of revision dates. Handle the distribution lists of SOP and also the archiving in the documents system (DMS).
- Ensure accurate electronic archiving of all documents submitted to and also received from Proficient Authorities and also Notified Bodies. Along with accurate and also timely data update of regulatory compliance databases as well as a tool for assigned products.
- Assist the Regional RA Managers in the review of the list of ingredients for labelling purposes (eg. INCI and also INDI), & additionally aid them with artwork review and also approval.
- Track Proficient Authority web sites and databases for news related to new product registrations as well as parallel imports from the competition.
Aid Regional Regulatory team to deliver and also handle RA assessment, deliver Regulatory training as well as contribute to the Regulatory training plan and modules & assist in regulatory assessments in regulatory due diligence. Additionally, ensure participation in key meetings for the regulatory function and also provide timely feedback.
Internal clients and also partners such as the Regulatory Affairs Team in the EU region, Department/Section Managers, Professional and also Technical staff. Additionally, Peers in other Functions (Mainly Regulatory and Technology team yet may likewise include various other functions such as Quality, Marketing in the client locations).
Qualifications and also Experience:
- Bachelor’s degree in Pharmacy or pertinent education. Advanced degree favoured.
- Minimum 1 yr. of working experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.
- Understanding of registration as well as regulatory requirements in European countries.
- Knowledge of industry practices, techniques and standards, experience with medicinal products and also devices is an added advantage.
- Excellent digital literacy, working with electronic databases, eCTD software, MS Office applications. Also, Adobe Acrobat Standard or Professional, Google Suite, SAP, DMS, and Authority Regulatory databases as well as portals for handling changes as well as submissions.
- Outstanding interpersonal skills, good planning as well as organizing skills, the capability to work under stress and meet timelines. Proficiency in spoken and also written English.
- Additional language expertise such as French or German is an advantage.
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