Organon Hiring Associate Director, RA & PV, India

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

POSITION TITLE: Associate Director – Regulatory Affairs & Pharmacovigilance

based at Gurgaon

THE OPPORTUNITY

• This role provides you with the opportunity of leading India & neighboring countries in Regulatory Affairs & Pharmacovigilance domain. Being RAPV country lead you will have key role in CLT
• This role provides you with the opportunity to grow horizontally / vertically at country / Regional / HQ level

WHAT YOU WILL DO (Primary Responsibilities)

New Product(s) approvals

• Participate in discussion for new product launch planning with regional and HQ regulatory stake holders
• Develop regulatory registration strategy for all planned products portfolio mix in different therapeutic areas and class of products (pharmaceuticals, biologicals and medical device) for India and neighboring countries ( Pakistan, Sri Lanka, Bangladesh, Nepal, Maldives and Bhutan)
• Ensure successful execution of the registration strategy of all new products.

Product Life Cycle Maintenance

Co-ordinate with RA team to ensure renewals plan and on-time submission and approval of all products in TA’s to enable seamless supply of products.

Labelling and CMC PAC: Resolve any challenge with regional and global regulatory affairs team for requirement of variation package and its timely release.

Resolve any artwork and promotional material challenges and ensure compliance with the local regulations.

C. STAKEHOLDER MANAGEMENT (INTERNAL & EXTERNAL)

• Internal stakeholders: Attend CLT meetings and provide RA PV expertise to meet business objectives.

Work along with the different functions of the country, regional & HQ to resolve business issues

To keep business inform about changes in the regulatory landscape, impact of changed regulations and optimal resolution to ensure minimal/no damage to the business. Provide country regulatory updates to the regional and HQ team.

• External stakeholders:
• Maintain excellent relationship with the regulators both central and state FDA and work closely with them for grant of accelerated Licenses, mfg. site registration , Import Licenses , CT NOC , Govt Lab testing approvals , Loan Licenses & Whole sale Licenses etc.
• Policy advocacy:

To ensure regulatory changes have no/minimal impact on business.

• Policy advocacy along with various industrial pharma forums

ii) Policy advocacy along with regional and country corporate affairs lead

Leadership

• Lead internal and external RA PV audits/HA driven inspections.
• Lead at various Industrial/govt forums in shaping of the regulations to suit the company business.
• Mentor to the RAPV team and internal stake holders

D.pharmacovigilance Activities

• Responsible for overall PV activities for India and neighboring countries to always meet company and regulatory compliance
• Prepares for audits/inspections for countries/vendors covered by the country operation and actively participates in the audit and/or inspection. Provides recommendations of corrective and preventive actions (CAPA) and track CAPA commitments to address findings/observations and monitors until closure.
• Defines and develops local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
• Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures.
• Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions (i.e., new clinical trials, product launches, etc.)
• Serves as the local Qualified Person for PV (QPPV) / Local Responsible PV person (LRP)
• Finalize local SOP and ER
• PEOPLE MANAGEMENT
• Ensure complete RA PV team is in place.
• Work with L&D Team to cater development need of the RAPV team
• ADMINISTRATIVE ACTIVITIES
• Support to RA PV budgeting
• Provide RA PV inputs in agreements and contracts and sign off
• Vendor management

To Be Successful In This Role, You Must Have

WHAT YOU MUST HAVE (Required Experience and Skills):

• Leadership qualities
• Excellent knowledge of Drugs and Cosmetic Act 1940 and rules1945 , NDCT rules 2019, Medical device rules 2017 & biological guidelines .
• Excellent communication and Stake holder management skills
• Problem solving, working with different scenarios
• Fluent in English

Preferred Experience And Skills

• Experience: 10 to 15 years combined experience in leading Regulatory affairs & Pharmacovigilance . Experience managing neighboring countries Pakistan, Bangladesh and Sri Lanka

Education Minimum Requirements

• B.Pharm/M. Pharm/Ph.D

Apply HERE