Regulatory Associate

1 week ago


Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparency Dr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization Roles Responsibilities Perform searches in various patent databases screen relevant patents applications and prepare patent landscapes Prepare product reports including patent landscapes by exploring relevant regulatory databases Propose design-around strategies for relevant composition patents Conduct in-depth reading of patents prosecution histories perform Freedom to Operate analysis and support necessary IP clearances Support regulatory teams for necessary labeling changes Support Product Selection Portfolio teams with necessary IP diligences Identify prior art to support building invalidation grounds for blocking patents applications Provide technical support to legal teams during litigation patent oppositions Program Management Running the benefits program ensuring it aligns with business and HR goals monitoring progress and resolving technical issues Handling complex escalations and building relationships with internal teams to integrate benefits plans Creating collateral to explain proposed changes associated with benefits programs Benefits Excellence Establishing performance indicators and expectations for consistency accuracy and timeliness Identifying gaps and deficiencies in benefit administration processes making recommendations for improvements and implementing new processes Conducting regular quality audits on programs and suggesting ways to enhance speed and efficiency Compliance Analyzing reward data identifying potential anomalies with respect to legislation and staying abreast of legislative changes that impact rewards Highlighting risks of current practices and ensuring compliance with relevant regulations Qualifications Educational qualification Masters in Pharmacology Minimum work Experience 5-7 years of experience in Intellectual Property IP and formulation Skills attributes Technical Skills Experience in the Intellectual Property IP domain Skills in infringement invalidity analysis freedom to operate filing and prosecution Market launch analysis Experience in product identification and selection in perspective of complex Injectable inhalation OSDs in different geographies Sound knowledge of technologies used in various dosage forms Experience in due diligence in different geographies US Europe Australia Canada Japan India etc Behavioural Skills Excellent communication and interpersonal skills Strong analytical and problem-solving abilities Good negotiation and influencing skills Ability to work collaboratively with regulatory and cross-functional teams People management skills Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients API Oral formulations Parenteral Injectables Opthalmics Other dosages Our product development efforts drive a portfolio of more than 1 000 products Enabled by our robust R D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1 071 patents and also published over 1 000 papers for peer review over the years Benefits Offered At Dr Reddy s we actively help to catalyse your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddy s are on par with the best industry standards They include among other things and other essential equipment joining relocation support family support Maternity Paternity benefits learning and development opportunities medical coverage for yourself and your family life coverage for yourself Our Work Culture Ask any employee at Dr Reddy s why they come to work every day and they ll say because Good Health Can t Wait This is our credo as well as the guiding principle behind all our actions We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and we re always attuned to the new and the next to empower people to stay fit And to do this we foster a culture of empathy and dynamism People are at the core of our journey over the last few decades They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic For more details please visit our career website at



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