38 Regulatory Issues Jobs - Page 2

Role & responsibilities Work with senior managers to efficiently develop budget proposals, provide access to project finance information, and ensure contract/grant compliance and reporting Research revenue opportunities and economic trends, analyze internal operations, and identify areas for cost reduction and process enhancement Perform risk management through analysis of company liabilities and investments, and evaluate and manage capital structure and fundraising initiatives Monitor business performance with tracking tools, establish corrective measures as needed, and prepare detailed reports for earnings calls, management team, and rest of company Manage finance personnel and oversee financial IT systems, ensuring compliance with relevant regulatory entities (ex: Financial Accounting Standards Board, Internal Revenue Service, state attorneys general) Required skills and qualifications Five or more years of experience in executive leadership roles Excellent leadership skills, with steadfast resolve and personal integrity Exceptional verbal, written, and visual communication skills Understanding of advanced accounting, regulatory issues, and tax planning Working knowledge of how to raise capital outside traditional lines of credit Preferred skills and qualifications Masters degree (or equivalent experience) in accounting, business accounting, or finance International finance experience Experience in mergers and acquisitions and investor relations Executive experience with SaaS business models and their associated revenue recognition Professional certification (ex: Certified Public Accountant) Preferred candidate profile

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Liaison with Factories Directorate, PF Commissioner, PCB authorities, Ministry of Corporate affairs, WBIDC, Electricity Board, Land & Revenue etc. Taking appropriate measures to settle all corporate and Govt. disputes / issues arise in due course.

Roles and Responsibilities Manage government liaisoning activities for various departments, ensuring smooth communication between the company and relevant authorities. Coordinate with internal stakeholders to gather information and documentation required for regulatory approvals and licensing processes. Handle corporate affairs by maintaining records, preparing reports, and providing support on regulatory issues related to pharmaceutical products. Ensure timely submission of applications for approvals from concerned authorities, following up on their status until successful outcome. Provide guidance on regulatory compliance matters within the organization. Desired Candidate Profile 2-4 years of experience in Government Liasoning or Corporate Affairs in Pharma Industry. Integrated PG degree (Any Specialization) + M.A in Arts & Humanities or equivalent qualification. Strong understanding of government regulations governing pharmaceutical industry; knowledge of relevant laws, rules, and guidelines. Excellent communication skills with ability to build strong relationships with government officials at all levels.

Female Candidates are preferred recruitment.trinity@shyamgroup.com Role & responsibilities Coordinate and oversee the due diligence process for land acquisition, including title verification, land survey, environmental assessments and registration. Review legal documents such as purchase agreements, lease agreements, and other contracts related to land acquisition. Getting plan sanctioned, obtainment of Khaata, Conversion and Change of land use or any other such Liaison work related to project approval. Mutation of Land Preparing MIS as per requirement Proper upkeep of the Land records, purchase agreements and other relevant documents. Provide holistic support to the Site Team in all matters and getting permissions/clearances from authorities etc.

Role: Project Corporate Affairs Support - Deputy Manager Department: Corporate Affairs Location: Umrongso, Dima Hasao, Assam Qualification: MBA / MSW / LLB Job description: Support in executing the organizational growth & transformation goals, and protect & promote the reputation of the business in the region Minimize expenditure through effectively managing the departmental budget whilst consistently identifying and initiating cost saving initiatives Liaise with relevant departments in the region to ensure mitigation of regulatory risks by way of identifying, assessing and creating mitigation plans for the same Responsibility to manage PR and represent DCBL in front of various external stakeholders as per business requirements Focus on building sustainable relations at political, bureaucratic & other administrative levels Liaise with govt departments and local bodies as for matters pertaining to laws and adherence to legal requirements Co-ordinate with various departments to timely file claims and speedy processing of the incentive proposals Stay updated on the key happenings, movements, and other developments in the region and share relevant information's to Regional Corporate Affairs Head

Key Responsibilities Liaise with authorities such as SRA, PMRDA, PCMC, PMC, Collector Office, TLR Office, Talathi Office, Tahasildar, SDO, and Cantonment Board. Prepare and submit applications, affidavits, indemnity bonds, undertakings, etc., in prescribed formats as provided by architects or regulatory bodies. Coordinate for approvals such as Building Plan Sanction, Plinth Checking, Fire NOC, Garden NOC, Drainage NOC, and TDR utilization. Follow up with architect offices and partners for document collection and signatures. Handle interactions with the Sub-Registrar Office and JDR for adjudication, stamp duty refunds, and revenue certification. Manage applications and documentation for property tax, gram panchayat tax, etc. Maintain legal files and prepare legal document sets for Project APF. Independently type letters and applications using MS Word and Excel Candidate Requirements Education: Graduate (any discipline) Experience: 34 years in a similar role within the real estate sector Skills: Strong knowledge of real estate liaisoning processes and legal documentation Good written communication and document drafting skills Basic computer proficiency (MS Word and Excel) Ability to work independently and manage follow-ups with authorities

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Roles & responsibilities - Research and identify potential land suitable for acquisition. - Assess properties based on various factors such as location, zoning regulations, market conditions, and potential for development or investment. - Conduct feasibility studies and financial analyses to determine the viability of land acquisitions. - Perform comprehensive due diligence on potential properties, including title searches, environmental assessments, survey evaluations, and any other necessary investigations. - Coordinate with legal and environmental professionals to ensure compliance with regulations and identify potential risks or issues. - Initiate and lead negotiations with property owners, developers, brokers, and other relevant parties to secure favorable purchase terms. - Prepare and review legal documents, contracts, and agreements related to land acquisitions. - Collaborate with legal counsel to ensure compliance with legal requirements and minimize risks. - Collaborate with internal teams, such as development, finance, and legal, to align land acquisitions with organizational goals and objectives. - Liaise with external stakeholders, including local government officials, community groups, and landowners, to address concerns, secure permits, and gain necessary approvals. - Stay updated on industry trends, market conditions, and regulatory changes affecting land acquisitions. - Conduct market research and analysis to identify potential investment opportunities and emerging markets. - Establish and maintain relationships with landowners, developers, brokers, and other relevant stakeholders in the real estate industry. - Attend industry conferences, networking events, and trade shows to expand professional networks and stay informed about market developments. Qualifications and Skills: - Bachelor's degree in real estate, finance, business administration, or a related field (a relevant master's degree is a plus). - Proven 7+ years experience in land acquisition, real estate development, or a similar role. - Strong knowledge of real estate laws, regulations, and procedures. - Excellent negotiation and communication skills. - Analytical mindset with the ability to conduct financial analyses and feasibility studies. - Proficient in conducting due diligence on potential properties. - Ability to work independently and manage multiple projects simultaneously. - Strong attention to detail and organizational skills. - Proficiency in relevant software and tools, such as Microsoft Office Suite and real estate databases. ***Interested can share your resume @ hr@adesigntheory.com ***

Position involves managing all aspects of land acquisition and related processes for infrastructure and renewable power projects PAN India. Role requires strong coordination, legal understanding skills to ensure timely and compliant land procurement.

Role & Responsibilities: Strong exposure to Government Affairs, Policy Advocacy, and Legal Processes. Proven experience in relationship management with government authorities and regulatory bodies. Proficient in risk management, regulatory compliance, and stakeholder engagement. Sound understanding of Public Policy and Economic frameworks. Preferred Candidate Profile: Looking for 4 to 6 years of relevant experience in Policy Advocacy, Government Affairs, Documentation, Industry Associations, or related fields. Prior experience in the FMCG or Pharmaceutical industry will be an added advantage. Best regards, Vasanth Kumar 90477 44528 vasanthkumar.m@haarvard.com