Bhavana Salunke
Thane
Summary
Diligent Regulatory Affairs Managers with 12 years of Industry experience in Global Regulatory Affairs and strategic compliance management.
Skilled in CMC Dossier preparation, Submission compilation, Review, Query responses, Life cycle management and support to all other regulatory aspects of pre- and post-approval activities for the registration of Pharmaceutical products in European Region, Australia/New Zealand, ASEAN region, Emerging markets CIS, RUSSIA, Africa, MENA, LATAM regions.
Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
12
12
years of professional experience
Work History
Regulatory Affairs Manager
CONTINUUM INDIA
05.2021 - Current
- Managed to get approvals with queries from Health authorities for more than 50 submissions.
- Co-ordinate with R&D, QA, Global Technical Operations, Business Units, and others to contribute to European regulatory CMC strategies for submissions and product related activities.
- Identify required documentation for CMC submissions and delivery of documents in accordance with project timelines.
- Write or compile high-quality CMC documents during product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines.
- Review post-approval changes (change controls) and assess regulatory impact on affected registrations. Contribute to regulatory strategies and coordinate filings (e.g. NDA supplements, Variations and Renewals), as appropriate.
- Compile responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
- Communicate information and present status updates on product/project activities to key internal/external stakeholders of various levels.
- Assist in development of best practices for Regulatory Affairs processes.
- Maintain and archive regulatory documentation (as appropriate).
- Uses effective communication and employs influencing skills to establish key relationships with internal/external contacts.
- Keep knowledge up to date regarding quality guidelines and technical trends.
- Work collaboratively with global CMC colleagues and provide support, as required. Prepared and maintained document inventory for core dossier preparation.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Provided responses to regulatory agencies regarding product information or issues.
- Compilation, quality review, publishing and submission of Dossiers (DCP/MRP) and post approval
changes [variations (Type-IA, IB and II)] and renewals for life cycle management in EU market . - Compilation, review and submission of dossier (CTD & ACTD) and query response to emerging
markets. - Create, compile and validate eCTD submission for new submission and life-cycle management for
EU (MAA, variation and renewal) market. - Editing of PDF documents (creation of bookmarks and links).
- Preparation of presentations, SOPs and Work instructions for Internal training
- Handling of CEDMS software for document compilation and binder creation for new submissions & life cycle management
- Handling of Track-wise and Symphony systems for Change control management.
- Handling of Tru-vault system, Liquent-Insights for documents approvals and review.
- Handling of CAPRI system for preparing and review of APQR's.
DEPUTY MANAGER REGULATORY AFFAIRS
FLAMINGO PHARMACEUTICALS LTD
05.2012 - 08.2020
- Responsible for review and submission of registration dossiers for semi regulated market based on CTD/ACTD format and as per country specific requirements.
- Good Knowledge of Good Manufacturing Practices (cGMP), well versed with ICH Quality guidelines, CTD & ACTD formats.
- Successfully handled audits for Philippines FDA & PPB Kenya, Nigeria, Ghana, Client audits.
- Effectively co-ordinate and lead team of 14 members for preparing dossiers to register new products in ROW market as per requirement of Marketing department and renew products in expected time with respect to Registration status.
- Planning of dossiers to be submitted and answering queries in stipulated time.
- Co-ordination with Country Managers, factory personnel for any queries in reply, documents or samples.
- To support Marketing, country managers and agents for effective submission of dossiers.
- To prepare and maintain Registration and document status which are sent to all countries.
- To co-ordinate with Purchase, Artwork dept., Factory personnel, ARD, FRD and marketing for availability if samples, documents etc.
- To liaise for getting various Government Authorizations such as Notarization, Ministerial authorizations for FSC, COPP etc.
- To co-ordinate with concerned department for remittance and other formalities.
- Initiating new product development as advised by, co-ordination with concerned persons and departments and providing dossiers.
- Follow up and correspondence with importer/ agent/ country manager on registration status, new products, renewal and dossier submitted to MOH.
- Implementing functional manual for cross functional integration.
- MIS reporting through SAP.
- Ensuring samples are sent timely and coordinating with concerned person for submission, getting receipts and follow-up on registrations.
- Checking COAs before dispatch of Commercial Orders.
- Application of Product Permissions, COPPs, and coordination for addition of New Products in WHO GMP List.
- Checking of Artwork, Leaflets of both International and Domestic Supplies.
- Participate in writing and update SOP/Work Instructions and process improvements.
- Thorough review of FP data such as PDR/Process Validation/ understand intricacies of impurity profiling of FP with respect to API & their impact, FP-specifications and methods/detailed understanding of AMV requirements and parameters included/ stability etc.
- Co-ordination with API /PM vendors to resolve technical quires with respect to regulatory requirements.
- Well versed with Corporate Quality assurance role.
- Supported and reviewed various global change controls.
Education
M.Pharma - Pharmaceutics
Maharishi Arvind Institute of Pharmacy
Rajasthan03.2021
DRA- Chemist - Regulatory Affairs
Licenses & Certifications
Mumbai 02.2021
MBA - Pharmaceutical Marketing And Management
National Institute of Business Management
India01.2018
Post Graduate Diploma in Drug Regulatory Affairs - Regulatory Affairs
Institute of Pharmaceutical Education And Research
Pune, India09.2016
B. Pharma - Pharmacy
Gahlot Institute of Pharmacy
Mumbai04.2011
Skills
Technical Skill sets:
CMC Regulatory authoring and regulatory compliance
Query Responses/resolutions/renewals
Good knowledge of SAP, HPH, CEDMS, Track-wise and Symphony systems
Change controls management
Personal Skill sets:
- Having good hand in working with Microsoft Word, Micro Excel, Micro Power point and well versed with usage of internet and search engines for Regulatory updates
- Dedicated, Committed, Confident, Team Player and Self starter
- Quick Learner, Proactive and Good Analytical Skills
- Good planning and time management skills for handling multiple projects under strict timelines
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Timeline
Regulatory Affairs Manager
CONTINUUM INDIA
05.2021 - Current
DEPUTY MANAGER REGULATORY AFFAIRS
FLAMINGO PHARMACEUTICALS LTD
05.2012 - 08.2020
M.Pharma - Pharmaceutics
Maharishi Arvind Institute of Pharmacy
DRA- Chemist - Regulatory Affairs
Licenses & Certifications
MBA - Pharmaceutical Marketing And Management
National Institute of Business Management
Post Graduate Diploma in Drug Regulatory Affairs - Regulatory Affairs
Institute of Pharmaceutical Education And Research
B. Pharma - Pharmacy
Gahlot Institute of Pharmacy
Similar Profiles
Dr. Kirandeep BhuttaDr. Kirandeep Bhutta
Pharmacovigilance Scientist, Quality Scientist at Continuum IndiaPharmacovigilance Scientist, Quality Scientist at Continuum India
Mohd TahirMohd Tahir
Team Leader - Global Markets Operations & Middle Office – Client Assets Control Group at BA Continuum India Pvt. Ltd.Team Leader - Global Markets Operations & Middle Office – Client Assets Control Group at BA Continuum India Pvt. Ltd.
Subhatra ParthibanSubhatra Parthiban
SQL DBA Team - GWIM LOB at BA Continuum India Private Ltd. (BACI) - a non-banking subsidiary of Bank of AmericaSQL DBA Team - GWIM LOB at BA Continuum India Private Ltd. (BACI) - a non-banking subsidiary of Bank of America