Dr. Reddy’s Job vacancy for Multiple Positions – Call / Submit Resume to HR Email

• Qualification: M.Pharma, MS/M.Sc(Science) , Medical-MS/MD
• Experience : 02-20+years
• Role: Regulatory Affairs Manager, Medical Affairs Manager
• Job Location: Hyderabad/Secunderabad

Lead Regulatory NCE NBE

Objective: Dr. Reddys is seeking to establish a global Centre of Excellence dedicated to Oncology and Immunology. The organization will be based out of Hyderabad/Basel and will work with the objective of creating and implementing strategies to deliver on a portfolio of innovative assets in oncology and immunology.

The intent is to commercialize 5 NCEs/NBEs over the next 5 years with a potential 125 to 200 million dollars with India and Emerging Markets being the markets of priority (specifically Russia, Brazil, India & China).

Knowledge & Skills:

• Thorough understanding of the regulatory agencies requirements of various countries for NDAs, including the required format and content of the application.
• Excellent interpersonal, verbal and written communication skills (in English)
• Ability to work independently and collaboratively in a multidisciplinary team
• In-depth knowledge of submission and MAA management and associated processes
• Scientific Advice / Protocol assistance preparation
• Acceleration strategies & Expedited Pathways

Qualification & Experience:

• PhD, Masters in science / pharmacy, advanced degree preferred.
• Expert understanding of drug development process and understanding of scientific content and complexities related to NCEs/ NBEs
• Direct experience in developing strategy and leading teams through interactions with regulatory agencies in Emerging markets
• Around 10 years of overall experience in Industry with minimum 5 years’ experience in regulatory domain with knowledge new drug applications.
• Hands-on experience of clinico-regulatory requirements (DD, market study, CT strategy etc.) to enable filing NCE /NBE products across EM.

Roles and Responsibilities

• Preparing the NDA submission for Emerging Markets, communicating with regulatory agencies, and managing the regulatory review process. Ensuring that the drug is approved for marketing in a timely manner and that it meets the regulatory requirements for commercialization.
• Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies.
• Registration application preparation including administrative documents and GMP audit support for global markets.
• Preparation of gap analysis for the registration in regulated and semi regulated markets.
• Review, assessment and establishing & tracking effective change control management coming for regulatory review and approval.
• Work with a team of regulatory affairs experts of various countries to ensure that the NDA is submitted correctly and meets respective regulatory agencies requirements.
• Lead regulatory due diligence activities for innovative pipeline assets, identify necessary clinical and regulatory requirements needed for regulatory approval in Emerging Markets.
• Identify and assess regulatory risks, mitigations, opportunities, and contingencies.
• Liaise closely with the CMC and clinical teams to ensure all regulatory requirements are met and all information needed for ongoing documentation and registration is produced.
• Review Clinical trial protocols, Clinical study report contents and approval requirements to facilitate CT NOCs and marketing authorization approval by regulatory agencies
• Prepare meeting requests, briefing documents, coordinate and prepare teams for regulatory authority interactions. Establish and manage relationships with external regulatory authorities, prepare meeting requests, briefing documents, lead regulatory authority interactions and maintain correspondence / records of such interactions
• Ensure effective planning, preparation and timely submission of INDs, NDAs, BLAs and other regulatory documents and applications, as required
• Provide strategic direction (and content input) on product labelling
• Ensure adherence to and continuous improvement of standards, processes and guidelines for regulatory submissions of innovative products
• End to End RA function support for allocated asset/country: Guide by providing regulatory strategy for complex molecules/asset. Provide functional support to RA and CFT members to meet the current regulatory requirements and guidelines in order to secure the acceptances, approvals and launches of innovative assets.
• Accountable for decisions and appropriateness of submission documentation to support successful ANDAs/ANDSs/Dossiers and other submissions to various agencies.
• Deficiency Management: Coordinates and Collaborates with multi-disciplinary matrixed teams in relation to pending deficiencies to meet timelines with appropriate prioritization.
• Guides RA and CFT members by providing appropriate regulatory strategies to ensure the accuracy and adequacy of the response.
• Support the Launch team – Supports the launch team by providing necessary regulatory strategies, inputs and decisions for the proposed changes, if any, within the regulatory framework thus safeguarding the regulatory compliance and the launch of the product.
• Ensures the smooth transition of the approved and launched products to the Life-cycle Management (LCM) Process along with the history of approval process

Medical Affairs Manager: 

PURPOSE:

• To develop robust and relevant portfolio of differentiated products in haematology and oncology for countries of Emerging Markets (EM) for Dr. Reddys Laboratories (DRL).
• Evaluate current products for developing incremental innovations with advantages or overcoming challenges with current formulations, thereby improving health care of patients across geographies, and enhancing access of products. Working with cross functional teams of formulation development, regulatory affairs, Marketing CoE, other medical affairs colleagues and country teams for development of differentiated products.
• Provide scientific, medical, technical & clinical support for identification, assessment, and selection of new products in haematology and oncology.
• Evaluate the products under development at early stage of development from various sources including literature, BD & licensing opportunities to identify right products for the market.
• Connect with KOLs and conducting advisory boards for getting insight on therapy areas and the products under evaluations to arrive at right decision about product and help design strategy for launch of differentiated/new products.

Roles and Responsibilities

1. Ideation of novel or differentiated Onco-Haematology products

These products are not NCE/NBE or biosimilars but are novel products which carry differentiation over generic products in terms of one or more characters like convenience, safety, efficacy, etc.

This position will lead ideation of differentiated products in onco-haematology for disease areas in which DRL is present. Leading the process of identification of product, evaluating the product for its relevance & place in therapy.

2. Support evaluation & identification of new Onco-Haematology products

Support identification and evaluation of new products in Onco-haematology for therapies in which DRL is present to build robust and relevant future product pipeline.

Leading the product selection process through different steps of evaluation involving cross function stake holders within the organisation from medical perspective and provide necessary medical support and guidance to cross functional teams in deciding clinical, regulatory and product development strategy required for taking the new product to various countries of Emerging market.

Should scan new products under various stage of development and leverage insights derived from new pipeline products in development.

3. Conducting Ad boards and KOL meetings / interactions to get Insights on differentiated products

KOL feedbacks are an important part in decision making about differentiated products.

Identify the need and plan the ad boards of other suitable meeting format to get insight about the identified differentiated/new product and around relevant disease area from KOLs. Identifying KOLs, preparing the agenda of adbaord, and conducting adbaord and translating the insights into decision making pointer.

Guide country heads in process of identification, profiling and stratification of Key Opinion Leaders. Make panel of doctors in key therapy areas, conduct KOL meetings, take their assistance in identifying unmet medical needs, differentiated products, and getting inputs on differentiated/new products.

4. Evaluation of products identified by BD teams

Support the evaluation of new product proposals identified by BD teams from medical perspective and contribute in overall decision making for the molecule.

5. Contribute towards development of clinical and regulatory pathways

In view of differentiated/new product, the position will provide medical inputs to cross functional team of Regulatory and clinical development.

6. Help in developing strategy in differentiated product launches

Providing inputs in preparing strategy for launch of differentiated/new products when the selected product reaches to launch stage. To impart and pass on the learning and understanding of differentiated/new products to CoE and lead medical about the product enabling them to actively market.

7. Help in developing data generation plan and Post Marketing Studies for differentiated products

Help in strategizing the data generation plan and help in developing the post marketing study (PMS) or RWE etc for the differentiated/new product to lead medical oncology. Analyse and suggest, if possible, improvements in the clinical trial design.

8. Support for medico-marketing activities: Additional medico-marketing activities for existing and new products such as delivery of medical training sessions to marketing & sales teams, review and approval of promotional materials and support for RWE studies & digital marketing initiatives as needed.

Desired Candidate Profile

Qualification and Key areas of Expertise:

• MBBS and MD with Pharmacology or Medicine with overall experience of 5 years in medico-marketing function, preferably with exposure to oncology/haematology, new product development or evaluation of Oncology differentiated. NCE /NBE products (including biologicals and biosimilars)
• Past experience of conducting Advisory Board meetings with thought leaders
• Knowledge of clinical trials and regulatory pathways is necessary
• In-depth understanding about various cancers and principles of cancer therapy including latest products as well as upcoming treatment options and therapy modalities
• Experience and interest in critical evaluation of cancer trials and analysing the results in perspective of decision making about the selection of product

Behavioural attributes:

• Extrovert, proactive and self-driven, eager to connect with key stakeholders/external customers
• Good interpersonal relation skills with very good command on written and spoken English
• Good presentation skills along with good command of MS Office (PowerPoint, Excel and Word)
• Is team player and can work in diverse teams of cross function and lead the discussions
• Self-motivated and self-disciplined who can work to complete the projects / tasks within timelines.

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