CMC review of technical documentation for regulatory filings to various markets market: EU & UK, US- Gap Analysis and Remediation for module 3 -API Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients, Supporting and enabling effective and efficient communication that results in operational excellence. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies website. Education & Experience Master s degree in Pharma, Msc Chemistry Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years ) or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities Excellent technical data interpretation skills Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA) Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling documentation, preparation and review of non-CMC sections, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities Providing high-quality Clinical, Biopharmaceutical, Pharmacokinetic, non-clinical review of CTD sections for regulatory filings to SRA (e.g EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia) as well as agencies of ROW markets for DDReg clients Actively contribute to the development and implementation of regulatory strategies, processes and timelines for global approval. Carrying out Gap Analysis of Non-CMC sections for small molecules and biopharmaceuticals Authoring, and compiling CTDs sections, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Prepare &/or review labelling documentation, managing labelling changes, prepare variation application on labelling changes, intended for submission to the above-mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients. Supporting and enabling effective and efficient communication that results in operational excellence. Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website. Monitor competitive regulatory practices and actively review internal and external factors to mitigate potential problems. Ensure that draft labeling complies with all applicable regulations and guidelines Education & Experience Bachelor s or Master s degree in Pharma Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years ) or equivalent combination of education, training, & experience. Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong project management skills Excellent interpersonal skills including problem solving Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Assistant Manager Regulatory Affairs US - DDReg pharma Job Descriptions CMC review of technical documentation for regulatory filings to various markets market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs. Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients, Supporting and enabling effective and efficient communication that results in operational excellence. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies website. Education & Experience Master s degree in Pharma Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years ) or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities Excellent technical data interpretation skills Excellent interpersonal skills including problem solving Excellent oral and written communication skills with strong presentation skills Significant knowledge of US Regulations Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA) Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
AGM/Senior Manager - Regulatory Affairs - DDReg pharma Job Description Job title AGM/Senior Manager Reports to Director Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu / US / Canada / Japan / UK / Australia) in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities Providing high-quality CMC review of technical documentation for regulatory filings to various markets key market being Saudi & GCC, for DDReg clients Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs. Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients, Supporting and enabling effective and efficient communication that results in operational excellence. Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members. Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies website. Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems. Ensure that draft labeling complies with all applicable regulations and guidelines Education & Experience Bachelor s or Master s degree in Pharma Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job. Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong project management skills Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA) Apply Online A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
Manager Regulatory Affairs - EM - DDReg pharma Job Descriptions CMC review of technical documentation for regulatory filings to various markets market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN. Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients, Supporting and enabling effective and efficient communication that results in operational excellence. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies website. Education & Experience Master s degree in Pharma Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years ) or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities Excellent technical data interpretation skills Excellent interpersonal skills including problem solving Excellent oral and written communication skills with strong presentation skills Significant knowledge of US Regulations Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Location Gurgaon, Haryana (INDIA) Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
Drug Safety Physician (Gurgaon: On-site) - DDReg pharma Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects. Duties and responsibilities Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs. Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks. Communicating safety information to regulatory agencies, healthcare professionals, and the general public. Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed. Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs. Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety. Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards. Reviewing and evaluating the safety and efficacy of new drug candidates during the development and approval process. Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately. Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders. Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs. Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients. Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market. Being responsible for the overall safety of the drug, from preclinical development to post-approval. Education & Experience Bachelor s or Master s degree in Medical or Dental Sciences Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years ). Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong understanding of Medical Sciences Excellent interpersonal skills including problem solving Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time the incumbent may be required to working slots catering to different time zones Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
Assistant Manager Regulatory Affairs - EU - DDReg pharma Job Title: Assistant Manager Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4 6 Years Qualification: Master s Degree in Pharmacy (M.Pharm or equivalent) Role Overview We are seeking a proactive and detail-oriented Assistant Manager Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets , ensuring compliance with regional and international guidelines. Key Responsibilities Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets . Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards. Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications . Prepare and compile new CTD dossiers , variations , and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards. Critically review documentation to ensure internal consistency , compliance with regulatory expectations, and support regulatory excellence . Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions. Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines. Maintain high-level knowledge of current country-specific regulations , keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA). Education & Experience Master s degree in Pharmacy or equivalent qualification. 4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions. Equivalent combinations of education, training, and practical experience may also be considered. Key Skills & Competencies Strong technical skills in data analysis and interpretation of regulatory documentation. Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach. Effective negotiation and communication skills for liaising with internal teams and external agencies. Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards. Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word . Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly. Demonstrated ability to analyze data systematically , apply regulatory logic, and compile well-organized submissions. Collaborative, results-driven , and self-motivated with the flexibility to adapt to shifting priorities. Capable of delivering high-quality outputs under pressure and within aggressive timelines. Other Requirements Flexibility to work in cross-time-zone schedules , as needed to support global project coordination or agency interactions. Why Join Us? Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies. Apply Online First Name Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) +508 Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)
We are looking for a dynamic and results-driven Digital Marketing Executive to join our team. This role requires a passionate marketer with a solid foundation in SEO and social media marketing. The ideal candidate will be responsible for executing SE O strategies and managing our social media presence to increase brand awareness, drive website traffic, and generate qualified leads. Key Responsibilities: Conduct comprehensive keyword research, competitive analysis and implement on-page and off-page SEO strategies. Optimize website content, meta tags, images, content and URLs to improve search engine rankings. Monitor SEO performance using tools like Google Analytics, Search Console, SEMrush, Ahrefs, etc. Perform regular technical SEO audits and implement fixes. Stay up to date with the latest SEO trends and algorithm updates. Social Media: Plan, create, and schedule engaging content for platforms such as LinkedIn, Twitter, Facebook, and Instagram. Manage day-to-day social media activities, including responding to comments and engaging with followers. Track and analyze performance metrics (engagement, reach, conversions) to improve campaign results. Coordinate with the design and content teams to create visually appealing and relevant social media posts. Execute paid social media campaigns when required. Qualifications: Bachelor s degree in Marketing, Communications, or a related field. 1 3 years of hands-on experience in SEO and social media marketing. Strong understanding of SEO best practices, tools, and Google algorithm updates. Proficiency in social media platforms and content creation tools. Excellent written and verbal communication skills. Analytical mindset with the ability to interpret data and generate insights. Preferred Skills: Experience with Google Ads, Meta Ads Manager, and email marketing tools. Basic knowledge of HTML/CSS is a plus. Familiarity with marketing automation platforms and CRM tools. Employment Type: Full-Time Gurgaon (On-Site) Apply Online Last Name A valid email address is required. United States United Kingdom Albania (Shqip ri) American Samoa Antigua and Barbuda Austria ( sterreich) Azerbaijan (Az rbaycan) Belgium (Belgi ) Benin (B nin) Bosnia and Herzegovina ( ) Brazil (Brasil) British Indian Ocean Territory British Virgin Islands Burkina Faso Burundi (Uburundi) Cameroon (Cameroun) Cape Verde (Kabu Verdi) Caribbean Netherlands Cayman Islands Central African Republic (R publique centrafricaine) Chad (Tchad) Christmas Island Cocos (Keeling) Islands Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo) Congo (Republic) (Congo-Brazzaville) Cook Islands Costa Rica C te d Ivoire Croatia (Hrvatska) Cura ao Czech Republic ( esk republika) Denmark (Danmark) Dominican Republic (Rep blica Dominicana) El Salvador Equatorial Guinea (Guinea Ecuatorial) Estonia (Eesti) Falkland Islands (Islas Malvinas) Faroe Islands (F royar) Finland (Suomi) French Guiana (Guyane fran aise) French Polynesia (Polyn sie fran aise) Germany (Deutschland) Ghana (Gaana) Greenland (Kalaallit Nunaat) Guinea (Guin e) Guinea-Bissau (Guin Bissau) Hong Kong ( ) Hungary (Magyarorsz g) Iceland ( sland) Isle of Man Italy (Italia) Latvia (Latvija) Lithuania (Lietuva) Macedonia (FYROM) ( ) Madagascar (Madagasikara) Marshall Islands Mauritius (Moris) Mexico (M xico) Moldova (Republica Moldova) Montenegro (Crna Gora) Mozambique (Mo ambique) Myanmar (Burma) ( ) Namibia (Namibi ) Netherlands (Nederland) New Caledonia (Nouvelle-Cal donie) New Zealand Niger (Nijar) Norfolk Island North Korea ( ) Northern Mariana Islands Norway (Norge) Panama (Panam ) Papua New Guinea Peru (Per ) Poland (Polska) Puerto Rico R union (La R union) Romania (Rom nia) Saint Barth lemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (Saint-Martin (partie fran aise)) Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon) +508 Saint Vincent and the Grenadines San Marino S o Tom and Pr ncipe (S o Tom e Pr ncipe)