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Regulatory Associate

2 weeks ago

Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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.

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Job Description

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.

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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.

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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.

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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.

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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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