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Head Regulatory Affairs

0.00 to 2.00 Years   Pune   08 Nov, 2021
Boehringer
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaLegal Support Services,Sales / BD
EmploymentTypeFull-time

Job Description

*OUR COMPANYAt Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.THE POSITIONResponsible for providing subject matter expertise in the area of regulatory affairs strategy, compliance and logistics to ensure that Boehringer Ingelheim is able to establish and implement regulatory best practices in India, Sri Lanka, Nepal and Bangladesh. Manage regulatory strategic and logistical activities for the countries under responsibility and ensure necessary organisational to carry out all regulatory operational activities by coordinating efforts of various in-country regulatory affiliates, agents and Global Regulatory Affairs.Tasks & responsibilities

  • Liaise with Health Authority,consultants, agents and internal teams to guide input into regulatory strategies. Identification of regulatory risks associated with product registration and mitigation strategies to overcome it.
  • Develop and implement with Global RA effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements. Performance can be measure on the Timeliness of implementation.
  • Project and maintain an accurate Regulatory Affairs budget and managing external regulatory resources. Performance can be measured in Variance of not more than +- 5% to the planned budget.
  • Manage the performance of the team sets annual performance goals, monitors performance and provides constructive feedback to improve performance.
  • Identify their training and development needs and ensure fulfillment.
  • Develop and mentor subordinates to move to the next higher level of job. Develops career plans in consultation with HR.
  • Ensure compliance to Company policies and values.
Requirements
  • Education : Bachelors degree in Pharmacy or Life Science
  • Knowledge of Drugs and Cosmetic Act and Rules
  • Complex and evolving regulatory environment on interfaces of Clinical Operations, Supply Chain, Marketing, Sales, Finance, Medical Affairs and Industry associations.
  • In depth understanding of regulations in the country relevant for product registration and associated activities
  • Working knowledge of Pricing regulations
  • Working knowledge of port and HA administration
  • People Management, Influencing Skills, Negotiation skills, eye for details, analytical skills and networking skills.
  • Thorough understanding of HA working and processes
  • Good understanding of RA compliance KPIs
  • Expertise in D&C Act and D&C Rules, Awareness about DPCO, DMR
  • Basic IT Knowledge on MS Office applications
  • Role is based in Mumbai
WHY BOEHRINGER INGELHEIM With us, you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.READY TO CONTACT US Please contact our Recruiting Team: ***********@Boehringer-ingelheim.com, Tel: + 91-22-7********,

Keyskills :
working environmentenvironmental impact assessmentsubject matter expertiseoperational activitiessupply chainsalesnegotiation skillsanalytical skillsgymregulatory affairscoffeesalaryms officeproduct registrationmedical affairssupplymitig

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