Senior Manager , Regulatory Affairs

Bangalore, in

• Function: Research & Development
• Job Type: Full-time

Job ID: R00132786
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
Job Description

JOB SUMMARY

For defined therapeutic areas of responsibility, responsible for new product registrations, ongoing renewals, variations and maintenance of registered products and medical devices. Maintain regulatory systems and databases and provide support to the commercial team on marketing activities.
Markets: India, Sri Lanka, Nepal & Bangladesh.

PREFERRED QUALIFICATIONS AND EXPERIENCE:

• Education: Preferably Degree in Life Sciences or Biotechnology or Biomedical science equivalent to a B.Pharm/ M.Pharm/MSc degree.
• Experience: 13-15 years of experience in Regulatory Affairs for India region and Sri Lanka, Nepal & Bangladesh.

ESSENTIAL SKILLS AND ABILITIES:

• Team Player.
• Result oriented, ability to work in a fast-paced and evolving environment.
• Excellent communication and interpersonal negation skills.
• Strong functional and technical skills related to various dimensions of the regulatory affairs function.
• Strong project management and commercial skills.
• Regulatory agency interaction experience is advantage.
• Good track record on collaboration with Cross functional team.
• Strong interpersonal skills and proven track record in working effectively with cross functional teams.
• Having domain knowledge related to subregion country regulation is advantage.
• Ability to resolve the problem when it arises.

CODE OF CONDUCT & BUSINESS INTEGRITY

AbbVie is committed to observe high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
Candidate is therefore required to maintain the highest ethical standards in his conduct of Company affairs at all times and up hold the AbbVie Values.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.htm

• New Product Registration

• Develop regulatory strategies to achieve high-quality approvals for new products, line extensions, post-approval obligations, renewals, and other licenses in accordance with national regulations and aligned with business objectives.

• Plan, direct, coordinate, and control regulatory affairs activities related to identified potential products.
• Anticipate emerging regulatory issues and develop appropriate solutions.
• Ensure local regulatory strategies are aligned with global product strategies and priorities.
• Maintain in-depth knowledge of product portfolios, regulatory intelligence, and timelines to optimize submission strategies.
• Support Head of RA in preparing slides w.r.t regulatory pathway for new product registration / post approval commitments
• Search for information on competitor products, ongoing clinical trials, SEC data etc
• Prepare summary report on any potential generic infiltration.
• Prepare responses to queries raised by Area/ Global on the proposed regulatory pathway.
• Collaborate with the Area and Global for documentation for new product registration for all stages of registration for marketing in India.
• Collaborate and work on the presentation slides for Subject Expert Committee Meetings
• Arrange discussion and rehearsals with the Subject Matter Experts before the Subject Expert Committee Meetings
• Support Head of RA during the actual presentation in the Subject Expert Committee Meeting
• Circulation of the minutes of the meetings to the stakeholders and co-ordinate on the next steps or any action items
• Work closely with the Global SMEs on any query raised by the Agency for timely response submission.
• Work closely with the Reference standards team for sample procurement for testing purpose
• Co-ordinate with the laboratory for submission of samples and testing completion
• Submission of testing reports to the office of CDSCO and follow up on the final approval.
• Circulation of the approval to relevant stakeholders and Updation of database
• In case of any post approval commitment, co-ordinate with the SMEs on the completion of post approval commitment.
• Build and maintain strong relationships with regulatory agencies; contribute to portfolio planning committees.
• Monitor local and global regulatory changes to anticipate potential challenges.
• Evaluate the impact of changes in the regulatory environment and inform stakeholders of implications.
• Work with regulatory agencies to ensure amendments and updates to guidelines are in alignment with international standards.

• Uphold industry codes of conduct, ethical standards, and regulatory best practices.

Site Registration Certificate and Import Licences

• Ensure timely submission and approval of renewal of the licences.
• Guide Submission Manager to work on the documentation required for licence renewals.
• Review final documentation before submission
• In case of any query receipt from the Agency, review the queries and guide the Submission Manager on circulation to Area.
• Take part in the query discussion kick off meetings and agree on the timelines for submission.
• Review final query response document from Global, support Submission Manager to prepare locally driven responses.
• Approve the responses in COSMOS before Submission Manager proceeds with submission to Agency