Job Description

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)