3 Regulated Markets Jobs

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Consultant - Regulatory Affairs" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following: Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging markets Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs Providing strategic input to the Management and Partners on regulatory projects Keep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-8 years is mandatory Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc). Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets) CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit. Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills. Accuracy and attention to detail. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Role: Senior Manager Legal International Reports to: AVP - Legal Location : Govandi ( East ), Mumbai (alternate Saturday working ) Candidates from Pharma Industry only Extensive experience in out licensing Major Job Responsibility : Review and drafting of International Agreements: Drafting, vetting & negotiating various Agreements like In/Out License Agreement, Development Agts., Master Service Agreement (Clinical Trial / Non Clinical Trial), Manufacturing and Supply Agreement, Confidential Disclosure Agreement, Consultancy Agreement, Agency & Distribution Agreement, Liasioning Agreement, Retainer Agreement, Agreements related to product development, etc. Collaborate with the Business Development, Project Finance and sale team as well as with supporting areas (Finance, Admin, Accounting & HR) advising on legal risks, business strategies and other issues related to the Companys businesses. Periodic review of all standard templates and suggest amendments and suggest management on risk mitigating measures. Merger and Acquisition & Other Assist Sr. General Manager and General Counsel in reviewing data, agreements, conduct due diligence and prepare management reports in merger and acquisition deals. Advising on general business law issues and managing the legal issues of all areas of the company, including but not limited to corporate matters, procurement, safety, security, insurance and sustainability issues OTHERS: Ability to work independently and as a team member in reviewing and negotiating agreements with global customers. Should deliver high-quality work under deadlines. Proactively review the existing templates / agreements and highlight clauses that are required to be amended in the existing LSA's. Impart training to the other departments on following the SoP for contracts. Suggest to follow the internal process for tracking and completion of tasks. Coordinate with cross functional teams for discussion till execution of agreements. Maintain Contract Management Tool. Periodically conduct legal compliance audit of Manufacturing Plant, CnF Agent & Marketing Agent; Supporting other cross functional departments finance, marketing, regulatory, etc.,. Drafting POA, Loan recovery, etc;

Function: Biologics Position: Regulatory Affairs- CMC Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working) Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: 8-12 years Job Responsibilities: 1. Biosimilar Regulated market submissions - US / EU market submission 2. Biosimilar Product Development Strategy for CMC and Clinical 3. Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing) 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 5. MOH Query response 6. Biosimilar Product Life Cycle Management 7. RA support for Plant related QMS activities