Executive/ S. Executive Regulatory Affairs Bharat Serums and Vaccines

3.0 - 7.0 years

6 - 9 Lacs

Navi Mumbai

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Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must have exposure to in-licensed dossier filing and out licensing

Posted 1 week ago

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Vice President-US Market Out-Licensing- Business devpt For Pharma Archerchem Healthcare

10.0 - 20.0 years

20 - 35 Lacs

Mumbai Suburban, Navi Mumbai, Mumbai (All Areas)

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Job Summary: We are seeking an experienced and dynamic professional to lead out-licensing initiatives and drive business development activities for the US and European pharmaceutical markets. The ideal candidate will be responsible for identifying, negotiating, and executing strategic partnerships to out-license our portfolio of generic, specialty, or innovative pharmaceutical products. Key Responsibilities: Identify and evaluate potential partners in the US, Europe and UK for out-licensing of finished dosage formulations (FDFs), ANDAs, dossiers, or novel therapies. Develop and implement region-specificlicensing strategies aligned with company growth objectives. Manage the complete out-licensing cycle including lead generation, due diligence, term sheet negotiation, and contract closure. Build and maintain strong relationships with key stakeholders including pharma companies, distributors, and licensing consultants. Coordinate with internal departments like R&D, Regulatory, Legal, and Finance to support licensing discussions. Monitor competitive landscape, industry trends, and regulatory changes in the US and EU to inform business decisions. Participate in global partnering events, conferences (e.g., CPhI, BIO), and virtual meetings to source and pitch opportunities. Ensure proper documentation, pipeline updates, and deal tracking using CRM tools. Required Qualifications & Experience: Bachelors or Masters degree in Pharmacy, Life Sciences, or Business. MBA or equivalent post-graduate qualification preferred. Minimum 10–30 years of experience in business development, licensing, or alliance management in the pharmaceutical industry. Strong exposure to US FDA and EU regulatory environments and market dynamics. Proven track record of closing out-licensing deals or strategic alliances in regulated markets. Excellent negotiation, communication, and analytical skills. Ability to travel internationally as needed. Preferred Skills: . Understanding of intellectual property (IP), deal structures, and licensing models (upfront, milestone, royalty-based, etc.). Experience working with CDMOs or in a virtual pharma setting is a plus. Malad - Mumbai Salary Open Interested candidate please mail me your cv on hr@archerchem.com or what's up on 9028871352.

Posted 3 weeks ago

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Legal Manager/Sr. Manager Reliance Life Sciences (RLS)

8 - 12 years

20 - 30 Lacs

Navi Mumbai

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Role & responsibilities Drafting of in licensing/out licensing deals, Distribution agreements, Customer protection agreement, Clinical Trial Agreements, Collaborative Agreements, Non-Disclosure Agreements, Franchisee Agreement, Power of Attorneys, Leave & Licence Agreements, Memorandum of Understandings, Assignment Deeds, Trade Mark user Agreement, Affidavits, Legal Notices, Preferred candidate profile : Candidate should have 8 to 12 years of experience in Legal and must have hands on experience to: Maintain processes and system for effective Contract Management. Co-ordination with HR Partners in Field Staff related communication and initiation of Legal action. Appearance in Courts. Initiate legal action against defaulters and debtors. Recovery from debtors. Facilitate Trademark search to registration process Liaisioning with Legal counsels, consultants and advocates Co-ordination with cross functional teams in drafting contracts and agreements Filing of Trade Marks , oppositions , Attend the Hearings before the Trade Mark

Posted 1 month ago

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